(1294 days)
Augmentation of reconstructive treatment of the alveolar ridge
Filling of defects after root resection, apicoeccomy and cystectomy
Filling of extraction sockets to enhance preservation of the alveolar ridge
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for Bio-Oss® Blocks. It confirms that the device is substantially equivalent to a legally marketed predicate device. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details about a study to prove the device meets acceptance criteria.
The letter focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study report.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2000
Geistlich-Pharma C/O Mr. Peter S. Reichertz Attorneys at Law Arent Fox Kintner and Kahn, PLLC 1050 Connecticut Avenue, NW Washington, DC 20036-5339
K970569 Re : Bio-Oss® Blocks Trade Name: Regulatory Class: Unclassified Product Code: LYC Dated: May 14, 1998 Received: May 14, 1998
Dear Mr. Reichertz:
We have reviewed your Section 510(k) notification of intent to we have reviewed your section bronnewe have have determined the market the for market the device fererenced above and indications for device is substancially orgal as a legally marketed predicate use stated in interstate commerce prior to May 28, 1976, devices marketed in theor Medical Device Amendments, or to the enactment date or choclassified in accordance with the devices that have bech receral Food, and Cosmetic Act (Act).
provisions of the Federal Food, Drug, and Cosmetic the coperal provisions of the Federal rood, brag, asubject to the general rou may, therefore, maines of the general controls controls provisions of onclude requirements for annual provisions of the Act include requestood manufacturing practice, legistration, freems against misbranding and adulteration.
If your device is classified (see above) into either class II II your device is crabbliss (so(Premarket Approval), it may (Special Controls) of Crabb I controls. Existing major be subject to back adable can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ Federal Regulations, freis and ination assumes compliance with substantlarly equivalence aring Practice requirements, as set the Current Sood handsustem Regulation (QS) for Medical ne Quarry ByBoom (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug chrough periodre & _will verify such assumptions. Failure to Administracton (FBA) will voir vorm may result in regulatory comply with the GMF regult may publish further announcements action. In addition, Ibi may pages al Register. Please note: concerning your device in are ification submission does this response to your promosion you might have under sections 531
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Page 2 - Mr. Reichertz
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification"(21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Clus L/sr
Timothy A. Ulatowski
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): K970569
Device Name:_ Bio-Oss® Blocks
Indications For Use:
Augmentation of reconstructive treatment of the alveolar ridge
Filling of defects after root resection, apicoeccomy and cystectomy
Filling of extraction sockets to enhance preservation of the alveolar ridge
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rimmer
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_1c9 70548
Prescription Use _ (Per 21 CFR 801.109)
..............................................................................................................................................................................
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
§ 872.3930 Bone grafting material.
(a)
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.(b)
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.