TUTODENT DENTAL MEMBRANE

K073097 · Tutogen Medical U.S., Inc. · NPL · May 12, 2008 · Dental

Device Facts

• Record ID: K073097
• Device Name: TUTODENT DENTAL MEMBRANE
• Applicant: Tutogen Medical U.S., Inc.
• Product Code: NPL · Dental
• Decision Date: May 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This membrane is intended for use in oral surgical procedures as a resorbable material 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.

Device Story

TutoDent Dental Membrane and CopiOs Pericardium Membrane are resorbable bovine pericardium-derived barriers; processed via Tutoplast method. Used in oral surgery by clinicians for guided bone/tissue regeneration; augmentation around dental implants; alveolar ridge reconstruction; filling bone defects post-extraction or resection. Device acts as physical barrier to support tissue healing; prevents soft tissue ingrowth into bone defects. Supplied in various sizes; provides structural support during healing process before resorption.

Clinical Evidence

No clinical data provided. Substantial equivalence established through material characterization and comparison of design and function to predicate devices.

Technological Characteristics

Bovine pericardium processed via Tutoplast method; resorbable barrier membrane; dimensions 15x20mm to 30x40mm. No electronic, software, or active components.

Indications for Use

Indicated for patients undergoing oral surgical procedures requiring resorbable barrier membranes for guided bone and tissue regeneration, including implant site augmentation, alveolar ridge reconstruction, and bone defect filling following dental extractions or resections.

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

• TutoPatch membrane
• Collagen Dental Membrane
• Bio-Gide Resorbable Membrane
• BioMend Extend

Submission Summary (Full Text)

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161

MAY 12 2008

# RTI BIOLOGICS

ADVANCING SCIENCE, SAFETY & INNOVATION

# 510(K) Summary

K073097

April 17, 2008 Date:

Submitted by: Lisa Simpson RTI Biologics, Inc. 11621 Research Circle Alachua. FL 32615 Phone: [phone] x4326 Fax: [phone]

| Proprietary Names: | TutoDent® Dental Membrane |
|--------------------|-----------------------------------|
| | CopiOs™ Pericardium Membrane |
| Common Name: | Barrier, Animal Source, Intraoral |

Classification: Unclassified

Code Section: None

### Substantial Equivalence:

The TutoDent® Dental Membrane and CopiOs™ Pericardium Membrane are substantially equivalent to the TutoPatch membrane with respect to materials. The TutoDent® Dental Membrane and CopiOs™ Pericardium Membrane are substantially equivalent to the Collagen Dental Membrane, Bio-Gide Resorbable Membrane and BioMend Extend predicate devices with respect to design and function.

#### Description:

The TutoDent® Dental Membrane and CopiOs™ Pericardium Membrane are manufactured from bovine pericardium processed with the Tutoplast® process. These membranes are available in sizes ranging from 15 x 20mm to 30 x 40mm.

#### Intended Use:

This membrane is intended for use in oral surgical procedures as a resorbable material 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.

#### Summary of Technological Characteristics:

The TutoDent® Dental Membrane, CopiOs™ Pericardium Membrane, Collagen Dental Membrane, Bio-Gide Resorbable Membrane and BioMend Extend have substantially equivalent design and function. The TutoDent® Dental Membrane, CopiOs™ Pericardium Membrane and TutoPatch® membrane are composed of the same materials processed in the same manner.

11621 Research Greia + Algchua, FL 32016 + P.O Box 2650 + Alachoa, FL 32016 2660 Tel [phone] · 877.343.6892 · Fax [phone] · Customer Service 800.624.7238 · www.rtir.com

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or bird-like figure with stylized wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 12 2008

Ms. Lisa Simpson Director, Regulatory Affairs RTI Biologics, Incorporated P.O. Box 2650 11621 Research Circle Alachua, Florida 32616-2650

Re: K073097

Trade/Device Name: TutoDent® Dental Membrane CopiOs™ Pericardium Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Graft Material Regulatory Class: II Product Code; NPL Dated: April 17, 2008 Received: April 18, 2008

Dear Ms. Simpson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Simpson

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 (OS) 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 begin 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 vour 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/industry/support/index.html.

Sincerely vours.

Suyte Y. Michaelonis

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

Enclosure

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## Indications for Use:

510(k) Number (if known):

K073097

Device Name:

TutoDent® Dental Membrane CopiOs™ Pericardium Membrane

Indications For Use:

This membrane is intended for use in oral surgical procedures as a resorbable material 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.

V Prescription Use (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 IF NEEDED)

'목록========================================================================================================================================================================== Concurrence of CDRH, Office of Device Evaluation (ODE)

K. Muly for MSM

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K073097

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