(76 days)
Not Found
No
The summary describes a mechanical dental abutment and makes no mention of AI or ML.
No
The device, Nobel Biocare's SFB and CFB Angled Abutments, is described as a prosthetic component used in prosthetic rehabilitation, not a device that treats or cures a disease or condition.
No
Explanation: The device is described as premanufactured prosthetic components intended for use as an aid in prosthetic rehabilitation, and directly connected to dental implants. This function is related to treatment/rehabilitation rather than diagnosis. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description clearly states that the device is a physical, premanufactured prosthetic component (angled abutments) intended for use with dental implants. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the abutments are "premanufactured prosthetic components directly connected to the SFB & CFB endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation." This describes a device used in vivo (within the body) for structural support and restoration, not a device used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description further reinforces this by stating they are "artificial tooth abutments designed to fit and function on the SFB and CFB implants." This is a mechanical component for dental restoration.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information
Therefore, the Nobel Biocare SFB and CFB Angled Abutments are considered a medical device for dental restoration, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Nobel Biocare's SFB and CFB Angled Abutments are premanufactured prosthetic components directly connected to the SFB & CFB endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Product codes
NHA
Device Description
Nobel Biocare's SFB and CFB angled abutments are artificial tooth abutments designed to fit and function on the SFB and CFB implants. SFB and CFB angled abutments differ from the predicate SFB and CFB abutments in that the abutments are angled. The angled abutments provide for more flexibility in the implant placement and restoration process.
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
Not Found
Key Metrics
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
Image /page/0/Picture/0 description: The image shows a combination of letters and numbers, along with a date. The alphanumeric string "K062749" is prominently displayed in a bold, handwritten style. Above this string, the date "NOV 29 2006" is printed in a smaller, sans-serif font, indicating a specific date in November 2006.
510(k) Summary of Safety and Effectiveness 1.4
| Submitted by: | Ms. Phuong Nguyen Son
Regulatory Affairs Specialist |
|----------------------------------------|----------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC
22715 Savi Ranch Parkway
Yorba Linda, CA 92887 |
| Telephone: | (714) 282-4800, ext. 7830 |
| Facsimile: | (714) 282-9023 |
| Date of Submission: | September 13, 2006 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietary
or Model Name: | SFB & CFB Angled Abutments |
| Legally Marketed Device(s): | SFB & CFB Implants (K061003) |
Device Description:
Nobel Biocare's SFB and CFB angled abutments are artificial tooth abutments designed to fit and function on the SFB and CFB implants. SFB and CFB angled abutments differ from the predicate SFB and CFB abutments in that the abutments are angled. The angled abutments provide for more flexibility in the implant placement and restoration process.
Indications for Use:
Nobel Biocare's SFB and CFB Angled Abutments are premanufactured prosthetic components directly connected to the SFB & CFB endosseous dental implants and are intended for use as an aid in prostheit rehabilitation.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.
NOV 2 9 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Herbert Crane Director, Regulatory Affairs Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K062749
Trade/Device Name: SFB & CFB Angled Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: NHA Dated: September 13, 2006 Received: September 14, 2006
Dear Mr. Crane:
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 Federal Register.
2
Page 2 - Mr. Crane
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 yours,
Suva Runge
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: SFB & CFB Angled Abutments
Indications For Use:
Nobel Biocare's SFB and CFB Angled Abutments are premanufactured prosthetic components directly connected to the SFB & CFB endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
× 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 Runge
masthestology, General Huspitz.i ontrol, Dental Devi
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