(89 days)
The Nobel Biocare Centric Post is a support component indicated for use as an alignment post to center an abutment and as a seal to prohibit fluids from seeping into the implant interior.
The Nobel Biocare Centric Post is a component within the implant system, which is intended for use in restoring the chewing function of fully edentulous and/or partially edentulous patients.
The Nobel Biocare Centric Post is a support component indicated for use as an alignment post to center a temporary abutment and act as a seal to prohibit fluids from seeping into the implant interior during temporization.
The Nobel Biocare Centric Post is a component within the implant system, which is intended for use in restoring the chewing function of fully edentulous and/or partially edentulous patients.
Nobel Biocare's Centric Post is a hollow, accessory component designed to enhance the performance of the implant/abutment system by ensuring proper alignment between an abutment and an endosseous implant, while additionally acting as a seal that prevents fluids from seeping into the implant interior.
The Nobel Biocare Centric Post does not contact any mucous membranes in the oral cavity because it rests inside the implant/abutment interface. The Centric Post can only be used as part of the implant system, not on its own. It is designed to remain inside the implant/abutment interface for as long as the implant remains in the patient's mouth.
These attributes of the Nobel Biocare Centric Post enhance the performance of the implant/abutment system, such as the Nobel Perfect Implant System, and make the component desirable for use in fabricating both final restorations and temporary restorations.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Nobel Biocare Centric Post. This type of regulatory submission in the US is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with defined performance metrics as in a de novo or PMA submission for novel devices.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study to prove the device meets these criteria in the context of device performance, as it is focused on demonstrating substantial equivalence. It does not include:
- A table of acceptance criteria and the reported device performance: This document focuses on demonstrating that the Nobel Biocare Centric Post is substantially equivalent to existing legally marketed devices (Replace® Scalloped Margin Implant System and Nobel Perfect Implant System) based on its design, intended use, and materials, rather than presenting a performance study against predefined acceptance criteria.
- Sample size used for the test set and the data provenance: No performance testing data is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth or expert evaluation is mentioned for performance assessment.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone performance (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document primarily describes the device, its indications for use, and identifies predicate devices for the purpose of demonstrating substantial equivalence for 510(k) clearance.
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FEB 2 3 2004
510(k) Summary of Safety and Effectiveness 1.4
| Submitted by: | Elizabeth J. Mason, Sr. Regulatory Affairs Specialist |
|---|---|
| Address: | Nobel Biocare USA Inc.22715 Savi Ranch ParkwayYorba Linda, CA 92887 |
| Telephone: | (714) 282-4800, ext. 7830 |
| Facsimile: | (714) 998-9348 |
| Date of Submission: | November 21, 2003 |
| Classification Name: | Endosseous Implant (21 CFR 872.3640) |
| Trade or Proprietaryor Model Name: | Nobel Biocare Centric Post |
| Legally Marketed Device(s): | Replace® Scalloped Margin Implant System (K021584)Nobel Perfect Implant System (K030257) |
Device Description:
Nobel Biocare's Centric Post is a hollow, accessory component designed to enhance the performance of the implant/abutment system by ensuring proper alignment between an abutment and an endosseous implant, while additionally acting as a seal that prevents fluids from seeping into the implant interior.
The Nobel Biocare Centric Post does not contact any mucous membranes in the oral cavity because it rests inside the implant/abutment interface. The Centric Post can only be used as part of the implant system, not on its own. It is designed to remain inside the implant/abutment interface for as long as the implant remains in the patient's mouth.
These attributes of the Nobel Biocare Centric Post enhance the performance of the implant/abutment system, such as the Nobel Perfect Implant System, and make the component desirable for use in fabricating both final restorations and temporary restorations.
Indications for Use:
The Nobel Biocare Centric Post is a support component indicated for use as an alignment post to center an abutment and as a seal to prohibit fluids from seeping into the implant interior.
The Nobel Biocare Centric Post is a component within the implant system, which is intended for use in restoring the chewing function of fully edentulous and/or partially edentulous patients.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 2004
Ms. Elizabeth J. Mason Senior Regulatory Affairs Specialist Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K033724
Trade/Device Name: Nobel Biocare Centric Post Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: November 21, 2003 Received: November 26, 2003
Dear Ms. Mason:
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 Intersule ecomments of process 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 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 Writ), it may of basys 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 - Ms. Mason
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. or the rece of any - 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 (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 Division of Small Manufacturers, International and Consumer Assistance at its toll-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Owe
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
510(k) Number (if known): K033724
Device Name: Nobel Biocare Centric Post
Indications For Use:
The Nobel Biocare Centric Post is a support component indicated for use as an alignment post to center a temporary abutment and act as a seal to prohibit fluids from seeping into the implant interior during temporization.
The Nobel Biocare Centric Post is a component within the implant system, which is intended for use in restoring the chewing function of fully edentulous and/or partially edentulous patients.
Susan Quares
Division of Anesthesiology, General Hospital, Infection Control, Dental Devi
510(k) Number: K033724
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device E.valuation (ODE)
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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.)