K Number
K062846
Device Name
COLLAGEN DENTAL MEMBRANE III
Date Cleared
2006-10-13

(21 days)

Product Code
Regulation Number
872.3930
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Collagen Dental Membrane III is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Collagen Dental Membrane III is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect, or ridge augmentation to aid in wound healing.
Device Description
Collagen Dental Membrane III is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane III is supplied sterile, non-pyrogenic, in various sizes, and for single use only.
More Information

Not Found

No
The device description and performance studies focus on the material properties and biocompatibility of a collagen membrane, with no mention of AI or ML.

Yes.
The device is intended to aid in wound healing in dental surgery procedures, which is a therapeutic function.

No

The device description and intended use indicate it is a material for placement in dental surgery procedures to aid in wound healing, not for diagnosing conditions.

No

The device description clearly states it is a physical membrane matrix made from collagen, indicating it is a hardware device, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is for placement in the area of dental implant, bone defect, or ridge reconstruction/augmentation to aid in wound healing post dental surgery. This describes a device used in vivo (within the body) during a surgical procedure.
  • Device Description: The description details a resorbable membrane matrix made from collagen, designed to be placed within the body.
  • Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any such use or interaction with bodily specimens outside the body.

Therefore, the Collagen Dental Membrane III is a medical device used in vivo for surgical support and wound healing, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

Collagen Dental Membrane III is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery.

Product codes (comma separated list FDA assigned to the subject device)

LYC, NPL

Device Description

Collagen Dental Membrane III is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane III is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

dental implant, bone defect, ridge reconstruction, oral surgical procedures

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The device passed all applicable FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices. The results of the in vitro product characterization studies show that the device modification of the Collagen Dental Membrane III is safe and substantially equivalent to the original device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K011695

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 872.3930 Bone grafting material.

(a)
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.(b)
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.

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K062846

510(k) Summary of Safety and Effectiveness OCT 1 3 2006

| Applicant Name and Address: Collagen Matrix, Inc. | 509 Commerce Street
Franklin Lakes, New Jersey 07417 |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peggy Hansen, RAC
Sr. Director, Clinical, Regulatory, and Quality Assurance
Tel: (201) 405-1477
Fax: (201) 405-1355 |
| Date of Summary: | September 19, 2006 |
| Device Common Name: | Collagen Dental Membrane |
| Device Trade Name: | Collagen Dental Membrane III |
| Device Classification Name: | Bone Grafting Material
Class II
872.3930
LYC |
| Predicate Device(s): | Collagen Dental Membrane, K011695 |

Description of the Device

Collagen Dental Membrane III is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane III is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

Intended Use

Collagen Dental Membrane III is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery.

Summary/Comparison of Technical Characteristics

Collagen Dental Membrane III and its predicate have similar technological characteristics. In particular, the Collagen Dental Membrane III and its predicate are similar with respect to intended use, material, form, sizes, thickness, physical integrity, permeability and conformability.

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K062846

Safety

A Collagen Dental Membrane III equivalent has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all applicable FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.

Conclusion

The results of the in vitro product characterization studies show that the device modification of the Collagen Dental Membrane III is safe and substantially equivalent to the original device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Public Health Service

OCT 1 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850

Ms. Peggy Hansen, RAC Senior Director, Clinical, Regulatory and Quality Assurance Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K062846

Trade Name: Collagen Dental Membrane III Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPL Dated: September 20, 2006 Received: September 25, 2006

Dear Ms. Hansen:

This letter corrects our substantially equivalent letter of October 13, 2006.

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 80), please contact the Office of Compliance at (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Senjie y. Michue
m.D.

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

Image /page/3/Picture/7 description: The image is a circular seal with the text "FDA Centennial" in the center. The seal also contains the years "1906-2006" at the top. There are three stars below the word "Centennial". The text around the seal reads "Safeguarding and Promoting the Public Health of Our Nation".

Protecting and Promoting Public Health

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K062846

Indications for Use

062846 510(k) Number (if known):

Device Name: Collagen Dental Membrane III

Indications for Use:

Collagen Dental Membrane III is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect, or ridge augmentation to aid in wound healing.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

C 10(k) Number:

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kei Muluy for MSP

on Sign-Off) ision of Anesthesiology, General Hospital, Intection Control, Dental Devices

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