BIO-GIDE RESORBABLE BILAYER MEMBRANE

K960724 · Geistlich-Pharma · NPK · Jun 11, 1997 · Dental

Device Facts

• Record ID: K960724
• Device Name: BIO-GIDE RESORBABLE BILAYER MEMBRANE
• Applicant: Geistlich-Pharma
• Product Code: NPK · Dental
• Decision Date: Jun 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BIO-GIDE® is indicated for: - simultaneous use GBR-membrane (BIO-GIDE®) and implants: - augmentation around implants placed in immediate extract 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. Because of its elasticity, BIO-GIDE® has to be used in combination with space-making bone graft materials, e.g., autogenous bone, bone substitutes (BIO-OSS®, etc.)

Device Story

Bio-Gide is a resorbable bilayer membrane used in dental surgery to facilitate guided bone regeneration. It acts as a barrier to prevent soft tissue ingrowth into bone defect sites. Due to its elastic nature, it requires concurrent use with space-making bone graft materials (e.g., autogenous bone or Bio-Oss). The membrane is applied by dental clinicians during surgical procedures such as implant placement or ridge reconstruction. It provides a scaffold for bone healing and is eventually resorbed by the body, eliminating the need for a second surgical procedure for removal.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of device characteristics and intended use.

Technological Characteristics

Resorbable bilayer membrane; elastic material properties; intended for use as a barrier in guided bone regeneration; requires combination with space-making bone graft materials.

Indications for Use

Indicated for patients requiring guided bone regeneration (GBR) in conjunction with dental implants or bone defect repair, including immediate/delayed extraction sockets, localized ridge augmentation, alveolar ridge reconstruction, and filling of defects post-root resection, cystectomy, or tooth removal. Must be used with space-making bone graft materials.

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.

Reference Devices

• BIO-OSS®

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville, Maryland 20850

OCT 10 2007

Mr. Peter S. Reichertz
Attorney
Geistlich-Pharma
C/O Arent Fox Kintner Plotkin & Kahn
1050 Connecticut Avenue, N.W.
Washington, D.C. 20036-5339

Re: K960724
Trade Name: Bio-Gide Resorbable Bilayer Membrane
Regulation Number: 872.3930
Regulation Name: Bone Grafting Material
Regulatory Class: 2
Product Code: NPK
Dated: April 25, 1997
Received: April 25, 1997

Dear Mr. Reichertz:

This letter corrects our substantially equivalent letter of June 11, 1997.

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 (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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.

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.
Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health


Protecting and Promoting Public Health

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510(K) Number (if known): K960724

Device Name: BIO-GIDE® Resorbable Bilayer Membrane

Indications For Use:

BIO-GIDE® is indicated for: - simultaneous use GBR-membrane (BIO-GIDE®) and implants: - augmentation around implants placed in immediate extract 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. Because of its elasticity, BIO-GIDE® has to be used in combination with space-making bone graft materials, e.g., autogenous bone, bone substitutes (BIO-OSS®, etc.)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K960724

Prescription Use (Per 21 CFR 801.109) ☑
OR
Over-The-Counter Use ☐

(Optional Format 1-2-96)