(169 days)
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No
The document describes a ceramic dental abutment and its intended use with dental implants. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities. The performance studies described are laboratory tests of the device's physical properties.
No.
The device is a prosthetic restorative component designed to support dental implant-supported restorations in the mouth, not to treat or mitigate a disease.
No
The provided text describes a BioHorizons Ceramic Abutment, which is a prosthetic restorative component used with dental implants. Its purpose is to provide an artificial root structure or abutment for fixed bridgework and denture retention. There is no mention of the device performing any diagnostic function like detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a physical prosthetic component made from ceramic material, intended for use with dental implants. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for use with dental implants as an artificial root structure and abutments for prosthetic restorations. This is a surgical and restorative device, not a diagnostic test performed on samples from the human body.
- Device Description: The device is described as a prosthetic restorative component made of ceramic material for attachment to dental implants. This aligns with a medical device used in treatment, not diagnosis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device is clearly intended for use in a surgical and restorative dental procedure.
N/A
Intended Use / Indications for Use
BioHorizons Ceramic Abutments are intended for use in the anterior esthetic zone with BioHorizons Dental Implant-supported prosthetic restorations.
BioHorizons endosseous dental implants may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The BioHorizons Ceramic Abutment is a prosthetic restorative component intended for use with BioHorizons dental implants. This 510(k) submission notification is for the purpose of obtaining authorization to offer ceramic prosthetic abutments as part of endosseous implant systems manufactured and marketed by BioHorizons. The abutments are manufactured from ceramic material to BioHorizons design specifications, similar to the predicate Astra Tech device, and will be provided with a mating abutment screw for attachment to the implant.
In clinical practice the surgical placement and restorative procedures for the implants and abutments will not change. Ceramic abutments offer clinicians an esthetic treatment option with the more natural color tint of the ceramic when visible through gingival tissue, compared with the gray tint of titanium abutments.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
mandible and maxilla
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.)
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BioHorizons Implant Systems, Inc. Ceramic Abutments Special 510(k) September 22, 2006
510(k) summary 21 CFR 807.92
Winston Greer, Vice-President, QA & RA
NOV 2 2 2006
Date: September 22, 2006
Sponsor: BioHorizons Implant Systems. Inc. One Perimeter Park South Suite 230 South Birmingham, AL 35243 Tel: (205) 967-7880 Fax: (205) 870-0304
FDA/CDRH/GDE/PM0
2006 SEP 25 PM 12: 35
RECEIVED
Kouslon/AI
Proprietary Name
Official Contact:
Biohorizons Ceramic Abutment.
Common Name
Endosseous dental implant abutment.
Classification Name
Abutment, implant, dental, endosseous (21 CFR 872.3630, Product Code NHA),
Predicate Devices
Predicate devices are the Astra Tech Ceramic Abutment (K023631) and BioHorizons The Prodigy System Endosseous Implants (K042429). The cited Astra Tech device is a ceramic abutment with essentially the same indications for use as intended for the BioHorizons Ceramic Abutment. The cited BioHorizons devices are screw-type dental implant systems which include mating titanium abutment components, manufactured and distributed by the applicant. Authorization to legally market the predicate implant dental systems and Astra Tech ceramic abutment have been documented under the referenced 510(k) numbers.
Device Description
The BioHorizons Ceramic Abutment is a prosthetic restorative component intended for use with BioHorizons dental implants. This 510(k) submission notification is for the purpose of obtaining authorization to offer ceramic prosthetic abutments as part of endosseous implant systems manufactured and marketed by BioHorizons. The abutments are manufactured from ceramic material to BioHorizons design specifications, similar to the predicate Astra Tech device, and will be provided with a mating abutment screw for attachment to the implant.
In clinical practice the surgical placement and restorative procedures for the implants and abutments will not change. Ceramic abutments offer clinicians an esthetic treatment option with the more natural color tint of the ceramic when visible through gingival tissue, compared with the gray tint of titanium abutments.
1
BioHorizons Implant Systems, Inc. Ceramic Abutments Special 510(k) September 22, 2006
Intended Use
BioHorizons Ceramic Abutments are intended for use in the anterior esthetic zone with BioHorizons Dental Implant-supported prosthetic restorations. BioHorizons endosseous dental implants may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and dental retention. The basic indications and intended use of the BioHorizons ceramic abutment device are more restricted than described in predicate device labeling.
Technological Characteristics
The fundamental scientific technology of the ceramic abutment device is not changed from the predicate devices. All materials and processing methods remain substantially the same as the predicate devices.
Non-Clinical Testing
Laboratory testing was conducted on the "worst cast" (because of lesser wall thickness) 4.5mm Ceramic Abutment to determine device functionality and conformance to design requirements.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of several curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Winston D. Greer Vice-President, Quality Assurance & Regulatory Affairs BioHorizons Implant Systems, Incorporated One Perimeter Park South Suite 230 South Birmingham, Alabama 35243
NOV 2 2 2006
Re: K061567
Trade/Device Name: BioHorizons Ceramic Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 17, 2006 Received: November 20, 2006
Dear Mr. Greer:
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.
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 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 Foder. I Register.
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Page 2 -Mr. Greer
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Suytte Y. Michael O.m.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
: 上一篇:
510(k) Number: _____________________________________________________________________________________________________________________________________________________________
Device Name: BioHorizons Ceramic Abutments
Indications for Use:
BioHorizons Ceramic Abutments are intended for use in the anterior esthetic zone with BioHorizons Dental Implant-supported prosthetic restorations.
BioHorizons endosseous dental implants may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
RSBetz DDS for Dr Susan Rumer
| Prescription Use (per 21 CFR 801.109) | X | OR | Over-the-Counter Use |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- |