SOCKET GRAFT

K052493 · Steiner Laboratories · LYC · Jun 9, 2006 · Dental

Device Facts

• Record ID: K052493
• Device Name: SOCKET GRAFT
• Applicant: Steiner Laboratories
• Product Code: LYC · Dental
• Decision Date: Jun 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bone void filler for use in dental extraction sockets

Device Story

SOCKET GRAFT is a bone void filler intended for use in dental extraction sockets. It functions as a scaffold to support bone regeneration in the site of a tooth extraction. The device is intended for prescription use by dental professionals. It aids in the healing process by filling voids created after tooth removal, facilitating bone growth.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bone void filler material; classified under 21 CFR 872.3930; Product Code LYC.

Indications for Use

Indicated for use as a bone void filler in dental extraction sockets.

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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Public Health Service

SEP 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gregory Gene Steiner CEO Steiner Laboratories 590 Farrington Highway #524. Suite 132 Kapolei, Hawaii 96707

Re: K052493

Trade/Device Name: SOCKET GRAFT Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: May 26, 2006 Received: May 26, 2006

Dear Mr. Steiner:

This letter corrects our substantially equivalent letter of June 12, 2006.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your securermined the device is substantially equivalent (for the It it it cated above and have acteriminoure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to rialy 20, 1978, creclassified in accordance with the provisions of Amendinents of to de Heeb that har tic Act (Act) that do not require approval of a premarket the Federal Food, Drag, and Gerefore, market the device, subject to the general controls approvisions of the Act. The general controls provisions of the Act include requirements for provisions of the From - into & 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 If your device is classified (occ as a very controls. Existing major regulations affecting your (1 wirs), it thay be babyer 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 - Mr. 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 moan that I Dr mas mass statutes and regulations administered by other Federal agencies. of the Act of ally I oderal bakes are systements, including, but not limited to: registration r ou must comply with an art 807; labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF R Part 807), as ality systems (QS) regulation (21 CFR Part 820); and if requirelies as lectronic 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 1115 lotter will and in your of the FDA finding of substantial equivalence of your device to s logic premium no acresults 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] (http://www.fda.gov/cdrh/organiz.html#0C for OC organization structure). Also, please (ittp://www.idai.go/recence to preference to premarket notification" (21 CFR note the regulation other general information on your responsibilities under the I at 007:57); - 1 od may 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 yours,

Chris Lim, 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

known): K052493 (if Number 510(k)

Device Name: SOCKET GRAFT

Bone void filler for use in dental extraction sockets Indications For Use:

Over-The-Counter Use AND/OR × Prescription Use _ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruan

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