OSTIM

K030052 · Heraeus Kulzer, Inc. · LYC · Dec 6, 2004 · Dental

Device Facts

• Record ID: K030052
• Device Name: OSTIM
• Applicant: Heraeus Kulzer, Inc.
• Product Code: LYC · Dental
• Decision Date: Dec 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ostim is intended as a filling or reconstruction material for repair of bony defects in oral, gnathic and facial applications in the following indications: - Filling of intraoral bony defects such as those resulting from cytectomies, tooth tip resections, extractions or surgical tooth removal. - Augmentations in the area of the alveolar processes and maxillary sinuses. - Filling of periodontal defects.

Device Story

Ostim is a bone grafting material used for filling or reconstructing bony defects in oral, gnathic, and facial applications. It is applied by dental surgeons or clinicians during surgical procedures to address defects resulting from extractions, cystectomies, or periodontal disease, and for site augmentation in the alveolar process or maxillary sinuses. The material acts as a scaffold or filler to support bone repair. It is intended for prescription use only.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) premarket notification review.

Technological Characteristics

Bone grafting material for oral/maxillofacial surgical use. Material composition and specific technical standards are not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring repair of bony defects in oral, gnathic, and facial regions, including post-cystectomy, tooth tip resection, extraction, surgical tooth removal, alveolar process/maxillary sinus augmentation, and periodontal defect filling.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 2004

Ms. Cheryl V. Zimmerman Director, Ouality Operations & Regulatory Affairs Heraeus Kulzer, Incorporated 4315 South Lafavette Boulevard South Bend, Indiana 46614-2517

Re: K030052

Trade/Device Name: Ostim® Bone Grafting Material Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LYC Dated: October 19, 2004 Received: October 21, 2004

Dear Ms. Zimmerman:

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 vour 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. Zimmerman

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/dsma/dsmamain.html

Sincerely vours

Susan Russo

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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510(k) Number (if Known):

K030052

Device Name: Ostim® Bone Grafting Material

Indications For Use:

Ostim is intended as a filling or reconstruction material for repair of bony defects in oral, gnathic and facial applications in the following indications:

- Filling of intraoral bony defects such as those resulting from cytectomies, tooth tip I resections, extractions or surgical tooth removal.
- Augmentations in the area of the alveolar processes and maxillary sinuses. 제
- Filling of periodontal defects. ■

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

Concurrence of CDRH, Office of Device evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR Over-The-Counter Use **__**

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number. K030052