(89 days)
Not Found
No
The device description and intended use focus on a physical component (a post) for mechanical alignment and sealing within a dental implant system. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No
The device is described as a "support component" for an implant system, used to align an abutment and seal the implant, rather than directly treating a medical condition or restoring health. Its purpose is to facilitate the function of an implant system for restoring chewing function, which is a prosthetic or restorative purpose.
No
Explanation: The device is described as a support component and alignment post within an implant system, intended for restoring chewing function. Its function is mechanical (alignment, sealing) rather than diagnostic.
No
The device description clearly states that the Nobel Biocare Centric Post is a "hollow, accessory component" and a "support component," indicating it is a physical hardware device used within an implant system. There is no mention of software functionality.
Based on the provided text, the Nobel Biocare Centric Post is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's a support component within an implant system for restoring chewing function in patients. It's used in vivo (within the body) to align and seal components of a dental implant.
- Device Description: The description reinforces its role as an accessory component within the implant/abutment system, designed to remain inside the implant/abutment interface in the patient's mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
Therefore, the Nobel Biocare Centric Post is a medical device used in vivo for dental restoration, not an IVD.
N/A
Intended Use / 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.
Product codes
NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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)
Not Found
§ 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.)
0
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 Parkway | |
| Yorba 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 Proprietary | |
| or 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.
000008
1
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.
2
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
3
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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