(103 days)
BioHorizons Plastic Temporary Abutments are intended for short-term use of 30 days or less as a base for cemented or screw-retained crown and bridge restoration of dental implants, while esthetically contouring soft tissue.
BioHorizons Plastic Temporary Abutments are medical grade machined polyetheretherketone (PEEK) material, supplied sterile using gamma radiation for use as short-term (30 days or less) restorative dental implant abutments.
I'm sorry, but an acceptance criteria table and details about a study on device performance, including information about sample sizes, expert involvement, and ground truth establishment, are not present in the provided text. The document is a 510(k) summary for a dental device, focusing on its substantial equivalence to predicate devices based on design, material, and intended use, rather than a clinical performance study with defined acceptance criteria.
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FEB 1 4 2006
BioHorizons Implant Systems, Inc. BioHorizons Plastic Temporary Abutments 510(k) Notification October 28, 2005 revised February 14, 2006
510(k) Summary 21 CFR 807.92
Submitter's Name & Address
| Manufacturer: | BioHorizons Implant Systems, Inc.One Perimeter Park SouthSuite 230 SouthBirmingham, AL 35243Phone: (205) 967-7880Fax: (205) 870-0304 |
|---|---|
| Official contact:Date prepared: | Winston Greer, Vice-President, QA & RAOctober 28, 2005 |
Name of the Device
| Trade Name: | BioHorizons Plastic Temporary Abutments |
|---|---|
| Common or Usual Name: | Dental Implant Plastic Temporary Abutment |
| Classification Name: | Abutment, Implant, Dental, Endosseous |
| Classification Number: | NHA, 872.3630 |
Predicate Devices
-
- Friadent Esthicap, marketed by Dentsply International, York, Pennsylvania 17405, r navent Lathlop 1510(k) number K050208, concurrence date June 14, 2005.
- 2 Straumann RN synOcta Temporary Meso Abutment, marketed by Straumann Othuomaturing, Andover, Massachusetts 01810 , documented under 510(k) number K051717, concurrence date July 7, 2005.
Device Description
BioHorizons Plastic Temporary Abutments are medical grade machined polyetheretherketone (PEEK) material, supplied sterile using gamma radiation for use as short-term (30 days or less) restorative dental implant abutments.
Intended Use
BioHorizons Plastic Temporary Abutments are intended for short-term use of 30 days or less as a base for cemented or screw-retained crown and bridge restoration of dental implants, while esthetically contouring soft tissue.
Technological Characteristics
Technological Onarestones.
The fundamental scientific technology for the material, processing, and intended use of BioHorizons Plastic Temporary Abutments is essentially identical to the referenced predicate devices, making the BioHorizons Plastic Temporary Abutments substantially equivalent to all features of the prodicate devices which could affect safety or effectiveness because of the similarities in design, material and intended use.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the snakes and a horizontal line representing the staff. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2006
Mr. Winston Greer Vice-President Biohorizons Implant Systems, Incorporated One Perimeter Park South Suite 230, South Birmingham, Alabama 35243
Re: K053099
Trade/Device Name: BioHorizons Plastic Temporary Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 24, 2006 Received: January 26, 2006
Dear Mr. Greer:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becatermined the device is substantially equivalent (for the referenced above and had not 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 Amendinens, or to de roos and Cosmetic Act (Act) that do not require approval of a premarket the reachar Food; Drag). You may, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls providents of a 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 (I MA), it may of subject to back adatof Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh further announcements concerning your device in the Ecderal Register.
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Page 2 - Mr. Greer
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA s Issualled of a substanter ice complies with other requirements mean that FDA has made a decemination latin Journalism administered by other Federal agencies. of the Act of ally rederal statutes and regaraters, including, but not limited to: registration You music comply with an the Act 3 requirements and 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gift 801 (21 CFR Part 800); a and listing (21 CFR Part 607), lacemig (21 cegulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 .542 of the Ar requirements as set form in the quality systems (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) I his letter will anow you to begin mailering your device of your device to a premarket notification. THE PDF milling of subssification 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), If you desire specific advice for your device of your accommon at the regulation please contact the Other or Ochiphanes and (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 Division of 01638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runne
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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BioHorizons Implant Systems, Inc. BioHorizons Inforant Systems, inbutments 510(k) Notification Diol lonzono i IGSt. revised February 14, 2006
Page 1 of 1
510(k) Number: K053099
Device Name: BioHorizons Plastic Temporary Abutment
Indications for Use:
BioHorizons Plastic Temporary Abutments are intended for short-term use of days of BloHonzons Plastic Temporary Abuthernes crown and bridge restoration of dental icss as a while esthetically contouring soft tissue.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Dunn
(Division Sim-Off) Division of Anasthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: `K033049
Prescription Use (per 21 CFR 801 109) OR
Over-the-Counter Use _
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)