MESOTHELIUM DENTAL MEMBRANE

K121310 · Kensey Nash Corporation · NPL · Jul 11, 2013 · Dental

Device Facts

• Record ID: K121310
• Device Name: MESOTHELIUM DENTAL MEMBRANE
• Applicant: Kensey Nash Corporation
• Product Code: NPL · Dental
• Decision Date: Jul 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Mesothelium Dental Membrane is indicated for: simultaneous use of GBR-membrane and implants. 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. guided tissue regeneration procedures in periodontal defects.

Device Story

Resorbable porcine-mesothelium-derived extracellular matrix membrane; supplied as lyophilized sheet. Used in dental surgery for guided tissue and bone regeneration. Clinician trims membrane to fit defect site; placed over bone/implant site to act as cell-occlusive barrier. Prevents soft tissue ingrowth into bone defect; promotes bone regeneration. Sterile, single-use device.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Resorbable porcine-mesothelium-derived extracellular matrix. Lyophilized sheet form factor. Cell-occlusive. Sterile, double-layer packaging. Biocompatible and non-pyrogenic.

Indications for Use

Indicated for dental patients requiring guided tissue and bone regeneration, including ridge augmentation, alveolar reconstruction, and defect filling following extractions, resections, or cystectomies. For prescription use only.

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

• Bio-Gide® (K050446)
• CopiOs™ Pericardium Membrane (K073097)

Submission Summary (Full Text)

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K121310

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#### Mesothelium Dental Membrane

# JUL 1 1 2013

#### 510(k) Summary

DSM Biomedical Submitted by: 735 Pennsylvania Drive Exton, PA 19341 USA

Lori Burns, MS, RAC Contact Person: Manager Regulatory Affairs Ph: [phone] Fax: [phone]

July 2, 2013 Date Prepared: K121310 510(K) #:

Device:

| 'Trade Name: | Mesothelium Dental Membrane |
|--------------------------|-------------------------------------------------------------|
| Common/Usual Name: | Resorbable Membrane for Guided Tissue and Bone Regeneration |
| Classification Name: | Barrier, Animal Source, Dental |
| Proposed Classification: | 21 CFR 872.3930, Class II, NPL |

Device Description:

Mesothelium Dental Membrane is a barrier membrane for guided tissue and bone regencration in dental applications. It is a resorbable porcine-mesothelium-derived extracellular matrix available as a lyophilized sheet. Mesothelium Dental Membrane is available in a variety of shapes and sizes. Furthermore, the device can be casily trimmed or shaped to the appropriate size to fit the defect to be treated. The device is packaged sterile in a double-layer package.

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## Intended Use:

Mesothelium Dental Membrane is indicated for:

- . simultaneous use of GBR-membrane and implants.
- 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. .
- guided tissue regencration procedures in pcriodontal defects. .

## Predicate Devices:

| Manufacturer | Device | 510(k) |
|-----------------------------------------------------|---------|------------------------------|
| Ed. Geistlich Soehne Ag Fuer<br>Chemische Industrie | K050446 | Bio-Gide® |
| RTI Biologics | K073097 | CopiOs™ Pericardium Membrane |

## Technological Characteristics:

The intended use, product design, material, function and target population of Mesothelium Dental Membrancs are substantially equivalent to the FDA cleared and legally marketed predicate devices Bio-Gide (K050446) and CopiOs Pericardium Membrane (K073097).

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

…

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| Medical Device Name | Mesothelium Dental<br>Membrane | Bio-Gide | CopiOs Pericardium<br>Membrane |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Origin | Porcine | Porcine | Bovine |
| Device Characteristics | Extracellular matrix | Extracellular Matrix | Extracellular Matrix |
| | Cell-occlusive | Cell-occlusive | Cell-occlusive |
| | Implantable | Implantable | Implantable |
| | Resorbable | Resorbable | Resorbable |
| Intended Use | Mesothelium Dental<br>Membrane is<br>indicated for<br>simultaneous use of<br>GBR-membrane and<br>implants;<br>augmentation around<br>implants placed in<br>immediate extractions<br>sockets, augmentation<br>around implants<br>placed in delayed<br>extraction sockets,<br>localized ridge<br>augmentation for later<br>implantation, alveolar<br>ridge reconstruction<br>for prosthetic<br>treatment, filling of<br>bone defects after root<br>resection, cystectomy<br>removal of retained<br>teeth, guided bone<br>regeneration in<br>dehiscence defects,<br>guided tissue<br>regeneration<br>procedures in<br>periodontal defects. | Bio-Gide is indicated<br>for simultaneous use<br>of GBR-membrane<br>and implants;<br>augmentation around<br>implants placed in<br>immediate extractions<br>sockets, augmentation<br>around implants<br>placed in delayed<br>extraction sockets,<br>localized ridge<br>augmentation for later<br>implantation, alveolar<br>ridge reconstruction<br>for prosthetic<br>treatment, filling of<br>bone defects after root<br>resection, cystectomy<br>removal of retained<br>teeth, guided bone<br>regeneration in<br>dehiscence defects,<br>guided tissue<br>regeneration<br>procedures in<br>periodontal defects. | CopiOs is intended<br>for use in oral surgical<br>procedures as a<br>resorbable material<br>for augmentation<br>around implants<br>placed in immediate<br>extraction sockets,<br>augmentation around<br>implants placed in<br>delayed extraction<br>sockets; localized<br>ridge augmentation<br>for later implantation;<br>alveolar ridge<br>reconstruction for<br>prosthetic treatment;<br>filling of bone defects<br>after root resection,<br>cystectomy, removal<br>of retained teeth;<br>guided bone<br>regeneration in<br>dehiscence defects<br>and guided tissue<br>regeneration<br>procedures in<br>periodontal defects. |
| Biocompatibility | Yes | Yes | Yes |
| Non pyrogenic | Yes | Yes | Yes |
| Resorbable | Yes | Yes | Yes |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures connected by flowing lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W(066-G609 Silver Spring, MD 20993-0002

July 11, 2013

DSM Biomedical C/O Ms. Lori Burns, MS. RAC Manager, Regulatory Affairs 735 Pennsylvania Drive EXTON PA 19341

Re: K121310

Trade/Device Name: Mesothelium Dental Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: July 2, 2013 Received: July 5, 2013

Dear Ms. Burns:

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 application (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. 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.

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Page 2 - Ms. Burns

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 CFF Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known): _K121310

Device Name: Mesothelium Dental Membrane

Indications for Use: Mesothelium Dental Membrane is indicated for: simultaneous use of GBRmembrane and implants, 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.

The device is intended for one time use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Runner -S
Susan Run DDS, MA 2013.07.11
11:29:45-04'00'

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(Division Sign-Off) (Division Sign-On)
Division of Anesthestology, General Hospital Unfection Control, Dental Devices

s10(k) Number: K121510

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