Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack

K251062 · Geistlich Pharma AG · NPL · Aug 14, 2025 · Dental

Device Facts

Record IDK251062
Device NameGeistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack
ApplicantGeistlich Pharma AG
Product CodeNPL · Dental
Decision DateAug 14, 2025
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3930
Device ClassClass 2
AttributesTherapeutic

Intended Use

Geistlich Bio-Gide® is intended for the following uses: • augmentation around implants placed in immediate extraction sockets; • augmentation around implants placed in delayed extraction sockets; • localized ridge augmentation for later implantation; • alveolar ridge reconstruction for prosthetic treatment; • filling of bone defects after root resection, cystectomy, removal of retained teeth; • guided bone regeneration in dehiscence defects; and • guided tissue regeneration procedures in periodontal defects.

Device Story

Geistlich Bio-Gide family consists of resorbable bilayer porcine collagen membranes; porous surface facilitates bone-forming cell ingrowth; dense surface prevents fibrous tissue ingrowth. Used in dental surgery (e.g., ridge augmentation, implant site preparation) by clinicians. Membranes are non-cross-linked; sterilized via gamma irradiation. Some variants (e.g., Perio) include pre-formed templates to assist trimming. Combi-Kits include Geistlich Bio-Oss Collagen (natural bone mineral granules with collagen) for bone defect filling. Devices act as physical barriers to support guided bone/tissue regeneration. Clinical benefit: improved bone/tissue healing in dental defects.

Clinical Evidence

Bench testing only. Evaluation included surface morphology (SEM), porosity (ASTM F2450-18), tensile strength (ASTM F2150-19), thermal properties (DSC, ASTM F2212-20), suture pull-out, solubility, enzymatic degradation (ASTM F2212-20), protein molecular weight (SDS-PAGE, ASTM F2212-20), and hydration capacity. Viral safety verified per ISO 22442-3:2007. Biocompatibility, sterilization, shelf-life, and clinical performance data were leveraged from predicate devices (K212463, K171643).

Technological Characteristics

Material: Porcine collagen. Structure: Bilayer (porous/dense). Energy: None. Connectivity: None. Sterilization: Gamma irradiation. Standards: ASTM F2450-18, F2150-19, F2212-20; ISO 10993-1, 11137-1/-2/-3, 11607-1/-2, 22442-3. Form factor: Membrane sheets or pre-shaped forms; some kits include bone mineral granules (Bio-Oss Collagen).

Indications for Use

Indicated for dental patients requiring bone or tissue regeneration, including augmentation around implants in extraction sockets, ridge augmentation, alveolar reconstruction, filling of bone defects (post-resection/cystectomy/tooth removal), guided bone regeneration in dehiscence, and guided tissue regeneration in periodontal defects.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION Geistlich Pharma AG % Roshana Ahmed Sr. Regulatory Specialist Telos Partners LLC 2458 Frontier Drive Warsaw, Indiana 46582 August 14, 2025 Re: K251062 Trade/Device Name: Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: July 15, 2025 Received: July 15, 2025 Dear Roshana Ahmed: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1} 2K251062 - Roshana Ahmed Page Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} 3K251062 - Roshana Ahmed Page assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Sherrill Lathrop Blitzer for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K251062 | | | Device Name | | | Geistlich Bio-Gide® | | | Indications for Use (Describe) | | | Geistlich Bio-Gide® is intended for the following uses: • augmentation around implants placed in immediate extraction sockets; • augmentation around implants placed in delayed extraction sockets; • localized ridge augmentation for later implantation; • alveolar ridge reconstruction for prosthetic treatment; • filling of bone defects after root resection, cystectomy, removal of retained teeth; • guided bone regeneration in dehiscence defects; and • guided tissue regeneration procedures in periodontal defects. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K251062 | | | Device Name | | | Geistlich Bio-Gide® Shape | | | Indications for Use (Describe) | | | Geistlich Bio-Gide® Shape is indicated for: • augmentation around implants placed in immediate extraction sockets; • augmentation around implants placed in delayed extraction sockets; • localized ridge augmentation for later implantation; • alveolar ridge reconstruction for prosthetic treatment; • filling of bone defects after root resection, cystectomy, removal of retained teeth; and • guided bone regeneration in dehiscence defects. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {5} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K251062 | | | Device Name | | | Geistlich Bio-Gide® Compressed | | | Indications for Use (Describe) | | | Geistlich Bio-Gide® Compressed is indicated for: • augmentation around implants placed in immediate extraction sockets; • augmentation around implants placed in delayed extraction sockets; • localized ridge augmentation for later implantation; • alveolar ridge reconstruction for prosthetic treatment; • filling of bone defects after root resection, cystectomy, removal of retained teeth; • guided bone regeneration in dehiscence defects, and • guided tissue regeneration procedures in periodontal defects. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {6} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K251062 | | | Device Name | | | Geistlich Bio-Gide® Forte | | | Indications for Use (Describe) | | | Geistlich Bio-Gide® Forte is indicated for: • augmentation around implants placed in immediate extraction sockets; • augmentation around implants placed in delayed extraction sockets; • localized ridge augmentation for later implantation; • alveolar ridge reconstruction for prosthetic treatment; • filling of bone defects after root resection, cystectomy, removal of retained teeth; • guided bone regeneration in dehiscence defects, and • guided tissue regeneration procedures in periodontal defects. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {7} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K251062 | | | Device Name | | | Geistlich Bio-Gide® Perio | | | Indications for Use (Describe) | | | Geistlich Bio-Gide® Perio is intended for the following uses: • augmentation around implants placed in immediate extraction sockets; • augmentation around implants placed in delayed extraction sockets; • localized ridge augmentation for later implantation; • alveolar ridge reconstruction for prosthetic treatment; • filling of bone defects after root resection, cystectomy, removal of retained teeth; • guided bone regeneration in dehiscence defects, and • guided tissue regeneration procedures in periodontal defects. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {8} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K251062 | | | Device Name | | | Geistlich Combi-Kit Collagen | | | Indications for Use (Describe) | | | Geistlich Bio-Gide® is intended for the following uses: • augmentation around implants placed in immediate extraction sockets; • augmentation around implants placed in delayed extraction sockets; • localized ridge augmentation for later implantation; • alveolar ridge reconstruction for prosthetic treatment; • filling of bone defects after root resection, cystectomy, removal of retained teeth; • guided bone regeneration in dehiscence defects; and • guided tissue regeneration procedures in periodontal defects. | | | Geistlich Bio-Oss Collagen® is intended for the following uses: • augmentation or reconstructive treatment of the alveolar ridge; • filling of periodontal defects; • filling of defects after root resection, apicoectomy, and cystectomy; • filling of extraction sockets to enhance preservation of the alveolar ridge; • elevation of the maxillary sinus floor; • filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and • filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {9} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K251062 | | | Device Name | | | Geistlich Perio-System Combi-Pack | | | Indications for Use (Describe) | | | Geistlich Bio-Gide® Perio is intended for the following uses: • augmentation around implants placed in immediate extraction sockets; • augmentation around implants placed in delayed extraction sockets; • localized ridge augmentation for later implantation; • alveolar ridge reconstruction for prosthetic treatment; • filling of bone defects after root resection, cystectomy, removal of retained teeth; • guided bone regeneration in dehiscence defects; and • guided tissue regeneration procedures in periodontal defects. | | | Geistlich Bio-Oss Collagen® is intended for the following uses: • augmentation or reconstructive treatment of the alveolar ridge; • filling of periodontal defects; • filling of defects after root resection, apicoectomy, and cystectomy; • filling of extraction sockets to enhance preservation of the alveolar ridge; • elevation of the maxillary sinus floor; • filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and • filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {10} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG # 510(k) Summary # Geistlich Bio-Gide® ## I. Submitter Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: +41 41 492 55 55 Contact Person: Marco Steiner, Head Regulatory Affairs Management Date Prepared: August 14, 2025 ## II. Device | Device Proprietary Name: | Geistlich Bio-Gide® | | --- | --- | | Common or Usual Name: | Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration | | Classification Name: | Bone Grafting Material | | Regulation Number: | 872.3930 | | Product Code: | NPL | | Device Classification | II | ## III. Predicate Device Substantial equivalence is claimed to the following device: - Geistlich Bio-Gide®, K212463, Geistlich Pharma AG The following device was referenced within the submission: - Geistlich Bio-Gide Shape, Geistlich Bio-Gide® Compressed, K171643, Geistlich Pharma AG ## IV. Device Description Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. Page 1 of 23 {11} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG Geistlich Bio-Gide® is provided in the following sizes: - 13 x 25 mm - 25 x 25 mm - 30 x 40 mm - 40 x 50 mm ## V. Indications for Use Geistlich Bio-Gide® is intended for the following uses: - augmentation around implants placed in immediate extraction sockets; - augmentation around implants placed in delayed extraction sockets; - localized ridge augmentation for later implantation; - alveolar ridge reconstruction for prosthetic treatment; - filling of bone defects after root resection, cystectomy, removal of retained teeth; - guided bone regeneration in dehiscence defects; and - guided tissue regeneration procedures in periodontal defects. ## VI. Comparison of Technological Characteristics The Indications for Use Statement is identical to the predicate device. The subject device is equivalent to the predicate device with respect to material characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject device and predicate device have equivalent final product specifications. A comparison of the devices is provided in the table below. ### Technological comparison | | Subject Device | Geistlich Bio-Gide® (K212463) | Analysis | | --- | --- | --- | --- | | Material | Porcine collagen | Porcine collagen | The material of construction is identical. | | Sizes | 13 x 25 mm | 13 x 25 mm | The sizes offered are identical. | | | 25 x 25 mm | 25 x 25 mm | | | | 30 x 40 mm | 30 x 40 mm | | | | 40 x 50 mm | 40 x 50 mm | | | Single-Use | Yes | Yes | Both products are single use only. | | Sterilization | Gamma | Gamma | Both products use gamma irradiation. | Page 2 of 23 {12} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG The purpose of this submission is to notify the Agency of a new slaughterhouse for an existing supplier of animal sourced materials (K960724, K042197, K050446, K112572) as well as several non-significant changes to manufacturing facilities and equipment, as well as release testing methods. The differences between the subject and predicate device are addressed by the information provided within this submission. ## VII. Performance Data The following data were provided in support of the substantial equivalence determination: ### Physical and Biochemical Testing - Evaluation of surface morphology via Scanning Electron Microscopy (SEM) - Evaluation of pore characteristics via porosity testing based on ASTM F2450-18 - Evaluation of tensile strength by elongation measurements based on ASTM F2150-19 - Evaluation of onset temperature via Differential Scanning Calorimetry (DSC) based on ASTM F2212-20 - Evaluation of suture pull-out force by suture pull-out testing - Evaluation of device solubility by quantification of the extractable proportion - Evaluation of collagen degradation by enzymatic degradation based on ASTM F2212-20 - Evaluation of molecular weight distribution of proteins via SDS-PAGE based on ASTM F2212-20 - Evaluation of the hydration capacity by quantification of the swelling factor ### Other Experimental Testing - Viral safety per ISO 22442-3:2007 Results from in vitro and in vivo biocompatibility (K212463), sterilization (K212463 / K171643), shelf-life, (K171643) and bench (K171643) and clinical performance studies (K212463) from the applicant’s own predicate devices were leveraged in support of substantial equivalence. The following standards were utilized: ISO 10993-1:2018, ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2017, and ISO 11607-1/-2. ## VIII. Conclusion The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. In addition, the results of non-clinical testing demonstrate that the subject and predicate devices have equivalent performance. Therefore, it is concluded that Geistlich Bio-Gide® is substantially equivalent to the identified predicate device. Page 3 of 23 {13} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG # Geistlich Bio-Gide® Shape ## I. Submitter Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: +41 41 492 55 55 Contact Person: Marco Steiner, Head Regulatory Affairs Management Date Prepared: August 14, 2025 ## II. Device | Device Proprietary Name: | Geistlich Bio-Gide® Shape | | --- | --- | | Common or Usual Name: | Collagen Resorbable Bilayer Membrane Collagen Matrix | | Classification Name: | Bone Grafting Material | | Regulation Number: | 872.3930 | | Product Code: | NPL | | Device Classification | II | ## III. Predicate Device Substantial equivalence is claimed to the following device: - Geistlich Bio-Gide® Shape, K212463, Geistlich Pharma AG The following device was referenced within the submission: - Geistlich Bio-Gide Shape, Geistlich Bio-Gide® Compressed, K171643, Geistlich Pharma AG ## IV. Device Description Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Page 4 of 23 {14} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively. ## V. Indications for Use Geistlich Bio-Gide® Shape is indicated for: - augmentation around implants placed in immediate extraction sockets; - augmentation around implants placed in delayed extraction sockets; - localized ridge augmentation for later implantation; - alveolar ridge reconstruction for prosthetic treatment; - filling of bone defects after root resection, cystectomy, removal of retained teeth; and - guided bone regeneration in dehiscence defects. ## VI. Comparison of Technological Characteristics The Indications for Use Statement is identical to the predicate devices. The subject device is equivalent to the predicate device with respect to material characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have equivalent final product specifications. A comparison of the devices is provided in the table below. ### Technological comparison | | Subject Device | Geistlich Bio-Gide® Shape (K212463) | Analysis | | --- | --- | --- | --- | | Material | Porcine collagen | Porcine collagen | The material of construction is identical. | | Sizes | 14 x 24 mm (pre-shaped) | 14 x 24 mm (pre-shaped) | The sizes offered are identical. | | Single-Use | Yes | Yes | Both products are single-use only. | | Sterilization | Gamma | Gamma | Both products use gamma irradiation. | The purpose of this submission is to notify the Agency of a new slaughterhouse for an existing supplier of animal sourced materials (K960724, K042197, K050446, K112572) as well as several non-significant changes to manufacturing facilities and equipment, as well as release testing methods. The differences between the subject and predicate device are addressed by the information provided within this submission. Page 5 of 23 {15} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG ## VII. Performance Data The following data were provided in support of the substantial equivalence determination: ### Physical and Biochemical Testing - Evaluation of surface morphology via Scanning Electron Microscopy (SEM) - Evaluation of pore characteristics via porosity testing based on ASTM F2450-18 - Evaluation of tensile strength by elongation measurements based on ASTM F2150-19 - Evaluation of onset temperature via Differential Scanning Calorimetry (DSC) based on ASTM F2212-20 - Evaluation of suture pull-out force by suture pull-out testing - Evaluation of device solubility by quantification of the extractable proportion - Evaluation of collagen degradation by enzymatic degradation based on ASTM F2212-20 - Evaluation of molecular weight distribution of proteins via SDS-PAGE based on ASTM F2212-20 - Evaluation of the hydration capacity by quantification of the swelling factor ### Other Experimental Testing - Viral safety per ISO 22442-3:2007 Results from in vitro and in vivo biocompatibility (K212463), sterilization (K212463 / K171643), shelf-life, (K171643) and bench (K171643) and clinical performance studies (K212463) from the applicant’s own predicate devices were leveraged in support of substantial equivalence. The following standards were utilized: ISO 10993-1:2018, ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2017, and ISO 11607-1/-2. ## VIII. Conclusion The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. In addition, the results of non-clinical testing demonstrate that the subject and predicate devices have equivalent performance. Therefore, it is concluded that Geistlich Bio-Gide® Shape is substantially equivalent to the identified predicate device. Page 6 of 23 {16} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG # Geistlich Bio-Gide® Compressed ## I. Submitter Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: +41 41 492 55 55 Contact Person: Head Regulatory Affairs Management Date Prepared: August 14, 2025 ## II. Device | Device Proprietary Name: | Geistlich Bio-Gide® Compressed | | --- | --- | | Common or Usual Name: | Collagen Resorbable Bilayer Membrane Collagen Matrix | | Classification Name: | Bone Grafting Material | | Regulation Number: | 872.3930 | | Product Code: | NPL | | Device Classification | II | ## III. Predicate Device Substantial equivalence is claimed to the following device: - Geistlich Bio-Gide® Compressed, K212463, Geistlich Pharma AG The following devices were referenced within the submission: - Geistlich Bio-Gide Shape, Geistlich Bio-Gide® Compressed, K171643, Geistlich Pharma AG ## IV. Device Description Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Page 7 of 23 {17} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm. ## V. Indications for Use Geistlich Bio-Gide® Compressed is indicated for: - augmentation around implants placed in immediate extraction sockets; - augmentation around implants placed in delayed extraction sockets; - localized ridge augmentation for later implantation; - alveolar ridge reconstruction for prosthetic treatment; - filling of bone defects after root resection, cystectomy, removal of retained teeth; - guided bone regeneration in dehiscence defects, and - guided tissue regeneration procedures in periodontal defects. ## VI. Comparison of Technological Characteristics The Indications for Use Statement is identical to the predicate device. The subject device is equivalent to the predicate device with respect to material characteristics and sterilization methods, packaging, and size. Slight modifications to the manufacturing process of the predicate device were implemented to improve the handling properties of the subject device to facilitate use. No new manufacturing processes were introduced or removed when compared to the predicate device. Both the subject and predicate device have equivalent final product specifications. A comparison of the devices is provided in the table below. ### Technological comparison | | Subject Device | Geistlich Bio-Gide® Compressed (K212463) | Analysis | | --- | --- | --- | --- | | Material | Porcine collagen | Porcine collagen | The material of construction is identical. | | Sizes | 13 x 25 mm 20 x 30 mm | 13 x 25 mm 20 x 30 mm | The sizes offered are identical. | | Single-Use | Yes | Yes | Both products are single-use only. | | Sterilization | Gamma | Gamma | Both products use gamma irradiation. | The purpose of this submission is to notify the Agency of a new slaughterhouse for an existing supplier of animal sourced materials (K960724, K042197, K050446, K112572) as well as several non-significant changes to manufacturing facilities and equipment, as well as release Page 8 of 23 {18} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG testing methods. The differences between the subject and predicate device are addressed by the information provided within this submission. ## VII. Performance Data The following data were provided in support of the substantial equivalence determination: ### Physical and Biochemical Testing - Evaluation of surface morphology via Scanning Electron Microscopy (SEM) - Evaluation of pore characteristics via porosity testing based on ASTM F2450-18 - Evaluation of tensile strength by elongation measurements based on ASTM F2150-19 - Evaluation of onset temperature via Differential Scanning Calorimetry (DSC) based on ASTM F2212-20 - Evaluation of suture pull-out force by suture pull-out testing - Evaluation of device solubility by quantification of the extractable proportion - Evaluation of collagen degradation by enzymatic degradation based on ASTM F2212-20 - Evaluation of molecular weight distribution of proteins via SDS-PAGE based on ASTM F2212-20 - Evaluation of the hydration capacity by quantification of the swelling factor ### Other Experimental Testing - Viral safety per ISO 22442-3:2007 Results from in vitro and in vivo biocompatibility (K212463), sterilization (K212463 / K171643), shelf-life, (K171643) and bench (K171643) and clinical performance studies (K212463) from the applicant’s own predicate devices were leveraged in support of substantial equivalence. The following standards were utilized: ISO 10993-1:2018, ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2017, and ISO 11607-1/-2. ## VIII. Conclusion The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. In addition, the results of non-clinical testing demonstrate that the subject and predicate devices have equivalent performance. Therefore, it is concluded that Geistlich Bio-Gide® Compressed is substantially equivalent to the identified predicate device. Page 9 of 23 {19} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG # Geistlich Bio-Gide® Forte ## I. Submitter Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: +41 41 492 55 55 Contact Person: Head Regulatory Affairs Management Date Prepared: August 14, 2025 ## II. Device | Device Proprietary Name: | Geistlich Bio-Gide® Forte | | --- | --- | | Common or Usual Name: | Collagen Resorbable Bilayer Membrane Collagen Matrix | | Classification Name: | Bone Grafting Material | | Regulation Number: | 872.3930 | | Product Code: | NPL | | Device Classification | II | ## III. Predicate Device Substantial equivalence is claimed to the following device: - Geistlich Bio-Gide® Compressed, K212463, Geistlich Pharma AG The following device was referenced within the submission: - Geistlich Bio-Gide Shape, Geistlich Bio-Gide® Compressed, K171643, Geistlich Pharma AG ## IV. Device Description Geistlich Bio-Gide® Forte is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Page 10 of 23 {20} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG The Geistlich Bio-Gide® Forte membrane is available in five different sizes, 13 x 25 mm, 25 x 25 mm, 20 x 30 mm, 30 x 40 mm, and 40 x 50 mm. ## V. Indications for Use Geistlich Bio-Gide® Forte is indicated for: - augmentation around implants placed in immediate extraction sockets; - augmentation around implants placed in delayed extraction sockets; - localized ridge augmentation for later implantation; - alveolar ridge reconstruction for prosthetic treatment; - filling of bone defects after root resection, cystectomy, removal of retained teeth; - guided bone regeneration in dehiscence defects, and - guided tissue regeneration procedures in periodontal defects. ## VI. Comparison of Technological Characteristics The Indications for Use Statement is identical to the predicate device. The subject device is equivalent to the predicate device with respect to material characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have equivalent final product specifications. A comparison of the devices is provided in the table below. ### Technological comparison | | Subject Device | Geistlich Bio-Gide® Compressed (K212463) | Analysis | | --- | --- | --- | --- | | Material | Porcine collagen | Porcine collagen | The material of construction is identical. | | Sizes | 13 x 25 mm | 13 x 25 mm | The sizes offered are similar. | | | 25 x 25 mm | 20 x 30 mm | | | | 20 x 30 mm | | | | | 30 x 40 mm | | | | | 40 x 50 mm | | | | Single-Use | Yes | Yes | Both products are single-use only. | | Sterilization | Gamma | Gamma | Both products use gamma irradiation. | The purpose of this submission is to notify the Agency of an extension to the Geistlich Bio-Gide® product family to include Geistlich Bio-Gide® Forte as well as a new slaughterhouse for an existing supplier of animal sourced materials (K960724, K042197, K050446, K112572). The {21} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG differences between the subject and predicate device are addressed by the information provided within this submission. ## VII. Performance Data The following data were provided in support of the substantial equivalence determination: Physical and Biochemical Testing including comparative testing against the predicate device - Evaluation of surface morphology via Scanning Electron Microscopy (SEM) - Evaluation of pore characteristics via porosity testing based on ASTM F2450-18 - Evaluation of tensile strength by elongation measurements based on ASTM F2150-19 - Evaluation of onset temperature via Differential Scanning Calorimetry (DSC) based on ASTM F2212-20 - Evaluation of suture pull-out force by suture pull-out testing - Evaluation of device solubility by quantification of the extractable proportion - Evaluation of collagen degradation by enzymatic degradation based on ASTM F2212-20 - Evaluation of molecular weight distribution of proteins via SDS-PAGE based on ASTM F2212-20 - Evaluation of the hydration capacity by quantification of the swelling factor - Evaluation of device handling properties Other Experimental Testing - Viral safety per ISO 22442-3:2007 Results from in vitro and in vivo biocompatibility (K212463), sterilization (K212463 / K171643), shelf-life, (K171643) and bench (K171643) and clinical performance studies (K212463) from the applicant’s own predicate devices were leveraged in support of substantial equivalence. The following standards were utilized: ISO 10993-1:2018, ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2017, and ISO 11607-1/-2. ## VIII. Conclusion The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. In addition, the results of non-clinical testing demonstrate that the subject and predicate devices have equivalent performance. Therefore, it is concluded that Geistlich Bio-Gide® Forte is substantially equivalent to the identified predicate device. Page 12 of 23 {22} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG # Geistlich Bio-Gide® Perio ## I. Submitter Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: +41 41 492 55 55 Contact Person: Marco Steiner, Head Regulatory Affairs Management Date Prepared: August 14, 2025 ## II. Device | Device Proprietary Name: | Geistlich Bio-Gide® Perio | | --- | --- | | Common or Usual Name: | Collagen Resorbable Bilayer Membrane | | Classification Name: | Bone Grafting Material | | Regulation Number: | 872.3930 | | Product Code: | NPL | | Device Classification | II | ## III. Predicate Device Substantial equivalence is claimed to the following device: - Geistlich Bio-Gide® Perio, K212463, Geistlich Pharma AG The following device was referenced within the submission: - Geistlich Bio-Gide Shape, Geistlich Bio-Gide® Compressed, K171643, Geistlich Pharma AG ## IV. Device Description Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Page 13 of 23 {23} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG Pre-formed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio. ## V. Indications for Use Geistlich Bio-Gide® Perio is intended for the following uses: - augmentation around implants placed in immediate extraction sockets; - augmentation around implants placed in delayed extraction sockets; - localized ridge augmentation for later implantation; - alveolar ridge reconstruction for prosthetic treatment; - filling of bone defects after root resection, cystectomy, removal of retained teeth; - guided bone regeneration in dehiscence defects, and - guided tissue regeneration procedures in periodontal defects. ## VI. Comparison of Technological Characteristics The Indications for Use Statement is identical to the predicate device. The subject device is equivalent to the predicate device with respect to material characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have equivalent final product specifications. A comparison of the devices is provided in the table below. ### Technological comparison | | Subject Device | Geistlich Bio-Gide® Perio (K212463) | Analysis | | --- | --- | --- | --- | | Material | Porcine collagen | Porcine collagen | The material of construction is identical. | | Sizes | 16 x 22 mm | 16 x 22 mm | The sizes offered are identical. | | Single-Use | Yes | Yes | Both products are single-use only. | | Sterilization | Gamma | Gamma | Both products use gamma irradiation. | The purpose of this submission is to notify the Agency of a new slaughterhouse for an existing supplier of animal sourced materials (K960724, K042197, K050446, K112572) as well as Page 14 of 23 {24} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG several non-significant changes to manufacturing facilities and equipment, as well as release testing methods. The differences between the subject and predicate device are addressed by the information provided within this submission. ## VII. Performance Data The following data were provided in support of the substantial equivalence determination: ### Physical and Biochemical Testing - Evaluation of surface morphology via Scanning Electron Microscopy (SEM) - Evaluation of pore characteristics via porosity testing based on ASTM F2450-18 - Evaluation of tensile strength by elongation measurements based on ASTM F2150-19 - Evaluation of onset temperature via Differential Scanning Calorimetry (DSC) based on ASTM F2212-20 - Evaluation of suture pull-out force by suture pull-out testing - Evaluation of device solubility by quantification of the extractable proportion - Evaluation of collagen degradation by enzymatic degradation based on ASTM F2212-20 - Evaluation of molecular weight distribution of proteins via SDS-PAGE based on ASTM F2212-20 - Evaluation of the hydration capacity by quantification of the swelling factor ### Other Experimental Testing - Viral safety per ISO 22442-3:2007 Results from in vitro and in vivo biocompatibility (K212463), sterilization (K212463 / K171643), shelf-life, (K171643) and bench (K171643) and clinical performance studies (K212463) from the applicant’s own predicate devices were leveraged in support of substantial equivalence. The following standards were utilized: ISO 10993-1:2018, ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2017, and ISO 11607-1/-2. ## VIII. Conclusion The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. In addition, the results of non-clinical testing demonstrate that the subject and predicate devices have equivalent performance. Therefore, it is concluded that Geistlich Bio-Gide® Perio is substantially equivalent to the identified predicate device. Page 15 of 23 {25} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG # Geistlich Combi-Kit Collagen ## I. Submitter Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: +41 41 492 55 55 Contact Person: Marco Steiner, Head Regulatory Affairs Management Date Prepared: August 14, 2025 ## II. Device | Device Proprietary Name: | Geistlich Combi-Kit Collagen | | --- | --- | | Common or Usual Name: | Collagen Resorbable Bilayer Membrane Collagen Matrix | | Classification Name: | Bone Grafting Material | | Regulation Number: | 872.3930 | | Product Code: | NPM/NPL | | Device Classification | II | ## III. Predicate Device Substantial equivalence is claimed to the following device: - Geistlich Combi-Kit Collagen, K212463, Geistlich Pharma AG The following device was referenced within the submission: - Geistlich Bio-Gide Shape, Geistlich Bio-Gide® Compressed, K171643, Geistlich Pharma AG ## IV. Device Description Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation. Page 16 of 23 {26} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm. V. Indications for Use Geistlich Bio-Gide® is intended for the following uses: - augmentation around implants placed in immediate extraction sockets; - augmentation around implants placed in delayed extraction sockets; - localized ridge augmentation for later implantation; - alveolar ridge reconstruction for prosthetic treatment; - filling of bone defects after root resection, cystectomy, removal of retained teeth; - guided bone regeneration in dehiscence defects; and - guided tissue regeneration procedures in periodontal defects. Geistlich Bio-Oss Collagen® is intended for the following uses: - augmentation or reconstructive treatment of the alveolar ridge; - filling of periodontal defects; - filling of defects after root resection, apicoectomy, and cystectomy; - filling of extraction sockets to enhance preservation of the alveolar ridge; - elevation of the maxillary sinus floor; - filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and - filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). VI. Comparison of Technological Characteristics The Indications for Use Statement is identical to the predicate device. The subject device is equivalent to the predicate device with respect to materials characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate Page 17 of 23 {27} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG device have equivalent final product specifications. A comparison of the devices is provided in the table below. | | Subject Device | Predicate Device (K212463) | Analysis | | --- | --- | --- | --- | | Format | Convenience Kit | Convenience Kit | Both products are convenience kits. | | Kit Contents | Geistlich Bio-Oss Collagen® Geistlich Bio-Gide® | Geistlich Bio-Oss Collagen® Geistlich Bio-Gide® | The contents of the kits are identical. | | Sizes | Geistlich Bio-Gide®: 16 x 22 mm, Geistlich Bio-Oss Collagen® 100mg | Geistlich Bio-Gide®: 16 x 22 mm, Geistlich Bio-Oss Collagen® 100mg | The product sizes are identical. | | Single-Use | Yes | Yes | Both products are single-use only. | | Sterilization | Gamma | Gamma | Both products are gamma sterilized. | The purpose of this submission is to notify the Agency of a new slaughterhouse for an existing supplier of animal sourced materials (K960724, K042197, K050446, K112572) as well as several non-significant changes to manufacturing facilities and equipment, as well as release testing methods. The differences between the subject and predicate device are addressed by the information provided within this submission. ## VII. Performance Data The following data were provided in support of the substantial equivalence determination: ### Physical and Biochemical Testing - Evaluation of surface morphology via Scanning Electron Microscopy (SEM) - Evaluation of pore characteristics via porosity testing based on ASTM F2450-18 - Evaluation of tensile strength by elongation measurements based on ASTM F2150-19 - Evaluation of onset temperature via Differential Scanning Calorimetry (DSC) based on ASTM F2212-20 - Evaluation of suture pull-out force by suture pull-out testing - Evaluation of device solubility by quantification of the extractable proportion - Evaluation of collagen degradation by enzymatic degradation based on ASTM F2212-20 - Evaluation of molecular weight distribution of proteins via SDS-PAGE based on ASTM F2212-20 - Evaluation of the hydration capacity by quantification of the swelling factor Page 18 of 23 {28} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG ## Other Experimental Testing - Viral safety per ISO 22442-3:2007 Results from in vitro and in vivo biocompatibility (K212463), sterilization (K212463 / K171643), shelf-life, (K171643) and bench (K171643) and clinical performance studies (K212463) from the applicant’s own predicate devices were leveraged in support of substantial equivalence. The following standards were utilized: ISO 10993-1:2018, ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2017, and ISO 11607-1/-2. ## VIII. Conclusion The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. In addition, the results of non-clinical testing demonstrate that the subject and predicate devices have equivalent performance. Therefore, it is concluded that Geistlich Combi-Kit Collagen is substantially equivalent to the identified predicate device. Page 19 of 23 {29} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG # Geistlich Perio-System Combi-Pack ## I. Submitter Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: +41 41 492 55 55 Contact Person: Marco Steiner, Head Regulatory Affairs Management Date Prepared: August 14, 2025 ## II. Device | Device Proprietary Name: | Geistlich Perio-System Combi Pack | | --- | --- | | Common or Usual Name: | Collagen Resorbable Bilayer Membrane Collagen Matrix | | Classification Name: | Bone Grafting Material | | Regulation Number: | 872.3930 | | Product Code: | NPM/NPL | | Device Classification | II | ## III. Predicate Device Substantial equivalence is claimed to the following devices: - Geistlich Perio-System Combi Pack, K212463, Geistlich Pharma AG The following device was referenced within the submission: - Geistlich Bio-Gide Shape, Geistlich Bio-Gide® Compressed, K171643, Geistlich Pharma AG ## IV. Device Description Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio. Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Page 20 of 23 {30} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio. ## V. Indications for Use Geistlich Bio-Gide® Perio is intended for the following uses: - augmentation around implants placed in immediate extraction sockets; - augmentation around implants placed in delayed extraction sockets; - localized ridge augmentation for later implantation; - alveolar ridge reconstruction for prosthetic treatment; - filling of bone defects after root resection, cystectomy, removal of retained teeth; - guided bone regeneration in dehiscence defects; and - guided tissue regeneration procedures in periodontal defects. Geistlich Bio-Oss Collagen® is intended for the following uses: - augmentation or reconstructive treatment of the alveolar ridge; - filling of periodontal defects; - filling of defects after root resection, apicoectomy, and cystectomy; - filling of extraction sockets to enhance preservation of the alveolar ridge; - elevation of the maxillary sinus floor; - filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and - filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). Page 21 of 23 {31} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG ## VI. Comparison of Technological Characteristics The Indications for Use Statement is identical to the predicate device. The subject device is equivalent to the predicate device with respect to materials characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have equivalent final product specifications. A comparison of the subject and predicate device is provided in the table below. | | Subject Device | Predicate Device (K212463) | Analysis | | --- | --- | --- | --- | | Format | Convenience Kit | Convenience Kit | Both products are convenience kits. | | Kit Contents | Geistlich Bio-Oss Collagen® Geistlich Bio-Gide® Perio | Geistlich Bio-Oss Collagen® Geistlich Bio-Gide® Perio | The contents of the kits are identical. | | Sizes | Geistlich Bio-Gide® Perio: 16 x 22 mm, Geistlich Bio-Oss Collagen® 100mg | Geistlich Bio-Gide® Perio: 16 x 22 mm, Geistlich Bio-Oss Collagen® 100mg | The product sizes are identical. | | Single-Use | Yes | Yes | Both products are single-use only. | | Sterilization | Gamma | Gamma | Both products are gamma sterilized. | The purpose of this submission is to notify the Agency of a new slaughterhouse for an existing supplier of animal sourced materials (K960724, K042197, K050446, K112572) as well as several non-significant changes to manufacturing facilities and equipment, as well as release testing methods. The differences between the subject and predicate device are addressed by the information provided within this submission. ## VII. Performance Data The following data were provided in support of the substantial equivalence determination: ### Physical and Biochemical Testing - Evaluation of surface morphology via Scanning Electron Microscopy (SEM) - Evaluation of pore characteristics via porosity testing based on ASTM F2450-18 - Evaluation of tensile strength by elongation measurements based on ASTM F2150-19 - Evaluation of onset temperature via Differential Scanning Calorimetry (DSC) based on ASTM F2212-20 - Evaluation of suture pull-out force by suture pull-out testing - Evaluation of device solubility by quantification of the extractable proportion - Evaluation of collagen degradation by enzymatic degradation based on ASTM F2212-20 Page 22 of 23 {32} Geistlich Bio-Gide® Product Family K251062 Geistlich Pharma AG - Evaluation of molecular weight distribution of proteins via SDS-PAGE based on ASTM F2212-20 - Evaluation of the hydration capacity by quantification of the swelling factor Other Experimental Testing - Viral safety per ISO 22442-3:2007 Results from in vitro and in vivo biocompatibility (K212463), sterilization (K212463 / K171643), shelf-life, (K171643) and bench (K171643) and clinical performance studies (K212463) from the applicant’s own predicate devices were leveraged in support of substantial equivalence. The following standards were utilized: ISO 10993-1:2018, ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2017, and ISO 11607-1/-2. ## VIII. Conclusion The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. In addition, the results of non-clinical testing demonstrate that the subject and predicate devices have equivalent performance. Therefore, it is concluded that Geistlich Perio-System Combi-Pack is substantially equivalent to the identified predicate device. Page 23 of 23
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