(55 days)
Not Found
No
The device description and intended use focus on a mechanical component for alignment and sealing, with no mention of AI/ML terms or functions.
No
The device, a permanent centric post for dental implants, is described as a support component to align abutments and seal the implant interior, restoring chewing function. It is a mechanical component and does not directly treat or prevent a disease or condition, nor does it affect the structure or function of the body beyond its mechanical role in the dental implant system.
No
The device is described as a "support component" within an implant system, designed to align an abutment and seal the implant. Its purpose is to restore chewing function, not to diagnose a condition.
No
The device description clearly states it is a "hollow, accessory component" and a "support component," indicating it is a physical object, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states the Nobel Biocare Permanent Centric Post is a component within an endosseous implant system used in permanent restorations to restore chewing function. It is a physical device implanted in the body.
- The intended use and device description focus on mechanical function. The device is described as a support component for alignment and sealing within the implant/abutment interface. This is a structural and functional role within the body, not a diagnostic test performed on a sample.
Therefore, the Nobel Biocare Permanent Centric Post is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nobel Biocare Permanent Centric Post is a support component indicated for use as both an alignment post to center an abutment, and as a seal to prohibit fluids from seeping into the implant interior.
The Nobel Biocare Permanent Centric Post is a component within the implant system, and is intended for use in permanent restorations in order to restore the chewing function of fully edentulous and/or partially edentulous patients.
Product codes
NHA
Device Description
Nobel Biocare's Permanent 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 Permanent 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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
APR 2 8 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: | March 3, 2004 |
| Classification Name: | Endosseous Implant (21 CFR 872.3640) |
| Trade or Proprietary
or Model Name: | Nobel Biocare Permanent Centric Post |
| Legally Marketed Device(s): | Nobel Biocare Centric Post (K033724) |
Device Description:
Nobel Biocare's Permanent 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 Permanent 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.
Indications for Use:
The Nobel Biocare Permanent Centric Post is a support component indicated for use as both an alignment post to center an abutment, and as a seal to prohibit fluids from seeping into the implant interior.
The Nobel Blocare Permanent Centric Post is a component within the implant system, and is intended for use in permanent restorations in order to restore the chewing function of fully edentulous and/or partially edentulous patients.
Nobel Biocare USA, Inc. Traditional 510(k) Notification Nobel Biocare Permanent Centric Post March 2004
000008
1
Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a bird or other winged creature, possibly an eagle, with its wings spread. The image is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2004
Ms. Elizabeth J. Mason Senior Regulatory Affairs Specialist Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K040573
Trade/Device Name: Nobel Biocare Permanent Centric Post, Models 31234, 31235 Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: March 3, 2004 Received: March 9, 2004
Dear Ms Mason:
We have reviewed your Scction 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. Fxisting major regulations affecting your device can be found in the Codc 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. 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 (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-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Quls
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):
Device Name: Nobel Biocare Permanent Centric Post
Indications For Use:
The Nobel Biocare Permanent Centric Post is a support component indicated for use as both an alignment post to center an abutment, and as a seal to prohibit fluids from seeping into the implant interior.
The Nobel Biocare Permanent Centric Post is a component within the endosseous implant system, and is intented for use in permanent restorations in order to restore the chewing function of fully edentulous and/or partially edentulous patients.
× 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 Evaluation (ODE)
Řikuts Betz DDS for Dr. Susan Kinner
sthesiology, General Hospital Infection Control, Dental Device
Page 1 of 1
510(k) Number: K040573
000007