OSSEOCONDUCT

K101718 · Steiner Laboratories Div of Steiner Healthcare, LLC · LYC · Oct 26, 2010 · Dental

Device Facts

• Record ID: K101718
• Device Name: OSSEOCONDUCT
• Applicant: Steiner Laboratories Div of Steiner Healthcare, LLC
• Product Code: LYC · Dental
• Decision Date: Oct 26, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OsseoConduct is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. Specifically, for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including ridge augmentation, sinus lifts, craniofacial augmentation, filling of defects of endodontic origin, filling of cystic defects, filling of extraction sites, filling of lesions of periodontal origin, repair of traumatic defects of the alveolar ridge, filling of resection defects from bone tumors, cysts or other osseous defects, and a substitute for autogenous or allogenic bone grafts.

Device Story

OsseoConduct is a bone grafting material used to fill, augment, or reconstruct periodontal or bony defects in the oral and maxillofacial region. It serves as a substitute for autogenous or allogenic bone grafts. The device is intended for use by dental or oral/maxillofacial surgeons in clinical settings to treat conditions such as ridge augmentation, sinus lifts, cystic defects, and extraction sites. By providing a scaffold for bone repair, it facilitates the reconstruction of alveolar ridges and the healing of osseous lesions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bone grafting material classified under 21 CFR 872.3930 (Product Code: LYC).

Indications for Use

Indicated for patients requiring filling, augmentation, or reconstruction of periodontal or bony defects in the oral and maxillofacial region, including alveolar ridge deficiencies, sinus lifts, and various intraosseous defects.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dr. Gregory G. Steiner Chief Executive Office Steiner Laboratories Division of Steiner Healthcare LLC 590 Farrington Hwy, 524, Suite 132 Kapolei, Hawaii 96707

Re: K101718

OCT 2 6 2010

Trade/Device Name: OsseoConduct Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: October 20, 2010 Received: October 20, 2010

Dear Dr. Steiner:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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Page 2- Dr. Steiner

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Swan Runner

Anthony D. Watson, B.S., M.S., M.B.A. 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): K101718

OCT 2 6 2010

Device Name: OsseoConduct

OsseoConduct is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. Specifically, for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including ridge augmentation, sinus lifts, craniofacial augmentation, filling of defects of endodontic origin, filling of cystic defects, filling of extraction sites, filling of lesions of periodontal origin, repair of traumatic defects of the alveolar ridge, filling of resection defects from bone tumors, cysts or other osseous defects, and a substitute for autogenous or allogenic bone grafts.

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)

23

Susan Rogers

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

510(k) Number: