(513 days)
The BBP™ Bone Substitute is a bone filling augmentation material used for augmentation or reconstruction of the alveolar ridge, filling of periodontal bony defects, and filling of extraction sockets to enhance preservation of alveolar ridge.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "BBP™ Bone Substitute." It does not contain information about acceptance criteria or a study proving its performance.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory aspects like registration, labeling, and manufacturing practices, but does not include any performance data or study details.
Therefore, I cannot provide the requested information based on the provided text. The document does not describe acceptance criteria, device performance, sample sizes, ground truth establishment, or any information about a study.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2004
OCT USA, Incorporated C/O Mr. Kevin Walls Principal Consultant Regulatory Insight, Incorporated 13 Red Fox Lane Littleton, Colorado 80127
Re: K030195
Trade/Device Name: BBP Bone Substitute Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LYC Dated: April 8, 2004 Received: April 9, 2004
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reveal 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, of to arrives and Cosmetic Act (Act) that do not require approval of a premarket the Federal F 600; Drag). You may, therefore, market the device, subject to the general approvisions 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 (1 Nr.), It may of stay of 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 - Mr. Walls
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisod that 1 Dr. e levels mination that your device complies with other requirements mount mat r Dr mas mass statutes and regulations administered by other Federal agencies. of the Act of ally I oderal butter are quirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 867), lability (2) regulation (21 CFR Part 820); and if requirements as set form in the quality sion 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) This letter will anow you to objact finding of substantial equivalence of your device to a premarket nothreation. - The PDF 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), IT you desire specific at 110 to 10 years at (301) 594-4613. 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Driver (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu-Liang, Ph.D.
Chiu Lin, Ph.D. Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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K030195 510(k) Number (if known):
BBP™ Bone Substitute Device Name:
- Indications for Use: The BBP™ Bone Substitute is a bone filling augmentation material used for augmentation or reconstruction of the alveolar ridge, filling of periodontal bony defects, and filling of extraction sockets to enhance preservation of alveolar ridge.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 510(k) Number _ × Prescription Use (Per 21 CFR 801.109)
Anesthesiology, General Hospital.
510(k) Number: K630195
§ 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.