ENDOBON

K980679 · Biomet, Inc. · LYC · Apr 3, 1998 · Dental

Device Facts

• Record ID: K980679
• Device Name: ENDOBON
• Applicant: Biomet, Inc.
• Product Code: LYC · Dental
• Decision Date: Apr 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Endobon is used in the following dental and/or oral surgical procedures : - alveolar ridge augmentation/reconstruction - filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall - filling of periodontal bone pockets in the jaw (granules I) - filling bone defects after apicetomy - filling alveoli after tooth extraction Endobon® is available in pre-formed shapes (i.e. blocks or cylinders) and granules sizes. This material is intended to fill voids or defects in bone and should not be used in nonperiodontal mandibular applications.

Device Story

Endobon is a porous hydroxyapatite ceramic bone substitute derived from bovine cancellous bone. It is used by dental surgeons to fill voids or defects in bone during oral surgical procedures. The material is provided in pre-formed shapes (blocks or cylinders) or granules. It acts as a permanent, nonresorbable filler for bony defects. Clinical benefit is derived from its biocompatibility and ability to reconstruct bone structure in the alveolar ridge and jaw. The device is intended for prescription use only.

Clinical Evidence

Clinical, radiologic, and histologic findings from clinical trials demonstrate biocompatibility and suitability for the indicated dental procedures. Safety and effectiveness are supported by extensive preclinical studies and over five years of clinical experience.

Technological Characteristics

Porous hydroxyapatite ceramic (pentacalcium hydroxide [tris] phosphate) derived from bovine cancellous bone. Nonresorbable. Available in pre-formed blocks, cylinders, or granules. Mechanical bone substitute.

Indications for Use

Indicated for dental and oral surgical procedures including alveolar ridge augmentation/reconstruction, filling of resection defects in benign bone tumors or cysts, filling of periodontal bone pockets, filling bone defects after apicetomy, and filling alveoli after tooth extraction. Contraindicated for non-periodontal mandibular applications.

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.

Submission Summary (Full Text)

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K980679

APR - 3 1998

## 510(k) Summary of Safety and Effectiveness

Submitter: Biomet, Inc. P.O. Box 578 Airport Industrial Park Warsaw, IN 46581-0587 Contact Person: Mary L. Verstynen Product Code: 76LYC

Device Name: Endobon®

Endobon® is used in the following dental and/or oral surgical procedures :

- alveolar ridge augmentation/reconstruction ﻭ
- filling of resection defects in benign bone tumor, bone ﺍ cysts, or other defects in the alveolar ridge or wall
- filling of periodontal bone pockets in the jaw (granules I) l
- filling bone defects after apicetomy l
- filling alveoli after tooth extraction

Endobon® is available in pre-formed shapes (i.e. blocks or cylinders) and granules sizes. ( This material is intended to fill voids or defects in bone and should not be used in nonperiodontal mandibular applications.

Endobon® is a porous hydroxyapatite ceramic made from bovine cancellous bone. Hydroxyapatite (pentacalcium hydroxide [tris] phosphate) is both the main constituent of this ceramic bone substitute and a major constituent of the inorganic phase of human and animal bone. Endobon® is considered nonresorbable and is used to permanently fill or reconstruct bony Use of hydroxyapatite ceramics as bone substitutes defects. are well documented in the literature. In vitro and in vivo studies demonstrate that Endobon® has good biocompatibility and well tolerated by the human body.

The efficacy of Endobon® is based on biomechanical testing and clinical documentation. Clinical, radiologic, and histologic findings from clinical trials demonstrate the biocompatibility of Endobon® and confirmed its suitability for the desired indications.

The safety and effectiveness of Endobon® as a bone substitute has been determined in extensive preclinical studies and with over five years of clinical experience.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 1998

Mr. Mary L. Verstynen Clinical Research Manager Biomet® Incorporated P.O. Box 587 Warsaw, Indiana 46581-0587®

K980679 Re : Trade Name: Endobon Requlatory Class: II Product Code: LYC February 19, 1998 Dated: February 20, 1998 Received:

Dear Ms. Verstynen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements; as set --forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, FDA will verify such Failure to comply with the GMP regulation may assumptions. result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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## Page 2 - Ms. Verstynen

On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Reqister, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990. FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the requlation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beqinning on page 43447.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or [phone], or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmaman.html".

Sincerely yours,

Timothy A. Ulatowski

் மக்கள் வெள்ளி முறைய புக Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) NUMBER (IF KNOWN): | K180679 |
|---------------------------|---------|
|---------------------------|---------|

DEVICE NAME: Endobon

INDICATIONS FOR USE:

Endobon is used in the following dental and/or oral surgical procedures :

- alveolar ridge augmentation/reconstruction
- filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall
- Cysts, of other acreases in the jaw (granules I) ﺍ
- filling bone defects after apicetomy

- filling alveoli after after tooth axtraction

This product should not be used in non-periodontal mandibular applications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

n Al Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use \$\frac{No}{(Optional Format 1-2-96)}\$

Susan Runger
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K980674