(15 days)
Not Found
No
The 510(k) summary describes a standard dental abutment and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is a prosthetic device designed to restore chewing function, not to treat a disease or medical condition in a therapeutic sense.
No
The device is described as a prosthetic device (artificial tooth abutment) used to restore chewing function in partially edentulous patients. Its purpose is to replace a missing anatomical structure and restore function, not to diagnose a disease or condition.
No
The device description clearly states it is an "artificial tooth abutment" made from "titanium or zirconia," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Procera® Abutment Octagon is a prosthetic device designed to be implanted in the mouth to restore chewing function. It is a physical component that fits onto a dental implant.
- Intended Use: The intended use is to restore chewing function in partially edentulous patients by fitting onto a dental implant. This is a structural and functional restoration, not a diagnostic test performed on a sample.
The description clearly indicates it's a physical implant component, not a device used for analyzing biological samples.
N/A
Intended Use / Indications for Use
Nobel Biocare's Procera® Abutment Octagon is intended for use in the treatment of partially edentulous patients in order to restore chewing function. The Procera® Abutment Octagon is a prosthetic device that fits only the Straumann regular neck 4.8mm endosseous implant. The device has been developed for long-term, permanent use.
Nobel Biocare's Procera® Abutment Octagon is indicated for the treatment of partially edentulous palients Novel Bloodie of Food as that fit Straumann regular neck 4.8mm endosseous implants in order to restore chewing function.
Product codes
NHA
Device Description
The Procera® Abutment Octagon is an artificial tooth abutment designed to fit and function on the Straumann Dental Implant System regular neck 4.8mm endosseous implant.
Nobel Biocare's Procera® Abutment Octagon is intended for use in the treatment of partially edentulous patients in order to restore chewing function. The Procera® Abutment Octagon is a prosthetic device that fits only the Straumann regular neck 4.8mm endosseous implant. The device has been developed for long-term, permanent use.
Nobel Biocare's Procera® Abutment Octagon can be made from either titanium or zirconia.
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 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
041275
MAY
- 4 510(k) Summary of Safety and Effectiveness
| 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: | May 12, 2004 |
| Classification Name: | Endosseous Implant (21 CFR 872.3640) |
| Trade or Proprietary
or Model Name: | Procera® Abutment Octagon |
| Legally Marketed Device(s): | Esthetic Zirconia Abutment (K031719)
TiAdapt Abutment System (K971706)
ITI synOcta Meso Abutments (K033243) |
Device Description:
The Procera® Abutment Octagon is an artificial tooth abutment designed to fit and function on the Straumann Dental Implant System regular neck 4.8mm endosseous implant.
Nobel Biocare's Procera® Abutment Octagon is intended for use in the treatment of partially edentulous patients in order to restore chewing function. The Procera® Abutment Octagon is a prosthetic device that fits only the Straumann regular neck 4.8mm endosseous implant. The device has been developed for long-term, permanent use.
Nobel Biocare's Procera® Abutment Octagon can be made from either titanium or zirconia.
Indications for Use:
Nobel Biocare's Procera® Abutment Octagon is indicated for the treatment of partially edentulous patients requiring prosthetic devices that fit Straumann regular neck 4.8mm endosseous implants in order to restore chewing function.
1
Performance Standards 1.5
The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and The Glass if Opodar Ucharlor Dulanto Booknown Notertified as applicable to this submission.
2
Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
MAY 2 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth J. Mason Senior Regulatory Affairs Specialist Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K041275
Trade/Device Name: Procera® Abutment Octagon Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: May 12, 2004 Received: May 12, 2004
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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinente, of to co, 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 contrely provision 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 Ecderal Register.
3
Page 2 -Ms. Mason
Please be advised that FDA's issuance of a substantial equivalence determination does not I foast that FDA has made a determination that your device complies with other requirements modi that 1 Dr may Federal statutes and regulations administered by other Federal agencies. of the Act of ally I odetar statues and sequirements, including, but not limited to: registration Tour must compry with a 807); labeling (21 CFR Part 801); good manufacturing practice alle histing (21 et retri in the quality systems (QS) regulation (21 CFR Part 820); and if requirements 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) rms reter notification. The FDA finding of substantial equivalence of your device to a premarket notification - Free evice 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), 11 you don't be 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 may obtain 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,
Olin Liu, Ph.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
4
510(k) Number (if known):
K0412.75
Device Name: Procera® Abutment Octagon
Indications For Use:
Nobel Biocare's Procera® Abutment Octagon is indicated for the treatment of partially edentulous palients Novel Bloodie of Food as that fit Straumann regular neck 4.8mm endosseous implants in order to restore chewing function.
× 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)
Susan Rumps
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number:
Page 1 of 1
1.3
000007