OSTEOGRAF/D-300

K072052 · Dentsply International, Inc. · LYC · Aug 8, 2007 · Dental

Device Facts

• Record ID: K072052
• Device Name: OSTEOGRAF/D-300
• Applicant: Dentsply International, Inc.
• Product Code: LYC · Dental
• Decision Date: Aug 8, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, and filling of extraction sites.

Device Story

OsteoGraf/D-300 is a high-purity, high-density, nonresorbable, radiopaque, polycrystalline hydroxylapatite bone grafting material. It serves as a synthetic bone substitute for dental applications. The material is intended for use by dental professionals to treat periodontal defects, augment alveolar ridge bony defects, and fill extraction sites. It functions as a scaffold to support bone healing and structural integrity in the oral cavity.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by the established safety profile of the material components and their prior use in legally marketed devices.

Technological Characteristics

Material: High-purity, high-density, nonresorbable, radiopaque, polycrystalline hydroxylapatite. Form factor: Particulate. Conforms to applicable industry standards for dental bone grafting materials.

Indications for Use

Indicated for patients requiring treatment of intrabony periodontal defects, alveolar ridge augmentation, or filling of extraction sites.

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

• OsteoGraf/P (K891173)

Submission Summary (Full Text)

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K072052

# 510(k) SUMMARY

### AUG - 8 2007

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

CONTACT: Helen Lewis

DATE PREPARED: July 18, 2007

TRADE OR PROPRIETARY NAME: OsteoGraf/D-300

CLASSIFICATION NAME: Bone Grafting Material 21 CFR 872.3930

PREDICATE DEVICES: OsteoGraf/P, K891173

DEVICE DESCRIPTION: The OsteoGraf/D-300 material is a high purity, high density, nonresorbable, radiopaque, polycrystalline particulate form of hydroxylapatite, the major mineral phase of bone and dental enamel.

INTENDED USE: Treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, and filling of extraction sites.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in OsteoGraf/D-300 have been used in legally marketed devices and/or were found safe for dental use. The modifications made to the legally marketed device do not affect biocompatibility. Therefore, it was determined that biocompatibility testing was not necessary. OsteoGraf/D-300 conforms to applicable industry standards.

We believe that the prior use of the components of OsteoGraf/D-300 in legally marketed devices. the performance data provided, and biocompatibility support the safety and effectiveness of OsteoGraf/D-300 for the indicated uses.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized symbol. The symbol resembles an abstract representation of an eagle or bird in flight, composed of three curved lines. The text is arranged around the top and left side of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2007

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K072052

Trade/Device Name: OsteoGraf/D-300 Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: July 18, 2007 Received: July 26, 2007

Dear Ms. Lewis:

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. Lewis

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 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 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/industry/support/index.html,

Sincerely vours.

Chiu Lin, Ph.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

Enclosure

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### INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K072052

Device Name: OsteoGraf/D-300

#### Indications for Use:

OsteoGraf/D-300 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, and filling of extraction sites.

These are the same indications for use previously cleared for K891173.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

ision Sign-Off
Susa Putt

Civision of Anesthesiology, General Hospital Infaction Control, Dental Device

510(k) Number: K672352