(83 days)
No
The summary describes a physical prosthetic component (titanium abutment) and its intended use in dental rehabilitation. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The fabrication process is described as being based on a "design process" to achieve a personalized fit, which is typical for custom medical devices and does not inherently imply AI/ML.
No
The device is described as a "prosthetic component intended for use as an aid in prosthetic rehabilitation," which indicates it is a supportive or restorative device, not one that directly treats a disease or condition.
No
The device is described as a "premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation" and is fabricated to fit implants. It aims to achieve a personalized device that fits precisely and functions properly for individual patient needs, which are characteristics of a prosthetic device, not a diagnostic one.
No
The device description explicitly states it is a "premanufactured prosthetic component" and "fabricated to the exact shape, size, and specifications," indicating it is a physical hardware device (a titanium abutment).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "prosthetic rehabilitation" as a "premanufactured prosthetic component." This describes a device used in the body to replace or support a missing structure (a tooth in this case, supported by an implant).
- Device Description: The description focuses on the physical characteristics and function of the abutment as a component that fits with dental implants.
- 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.
IVD devices are used outside the body to analyze biological samples. This device is clearly intended for use inside the body as a dental prosthetic component.
N/A
Intended Use / Indications for Use
Nobel Biocare's Procera Titanium Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Procera Titanium Abutments fit the following endosseous implants:
- -AstraTech 3.5, 4.0, 4.5, 5.0 mm
- -Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
Product codes
NHA
Device Description
Nobel Biocare's Procera Titanium Abutment for AstraTech and Camlog Implant Systems is fabricated to the exact shape, size, and specifications determined in the design process in order to achieve a personalized device that fits precisely, and properly functions, according to each patient's individual needs.
Nobel Biocare's Procera Titanium Abutment for AstraTech and Camlog Implant Systems is similar in design, intended use, and operation to the abutments cleared in predicate devices.
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)
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
510(k) Summary of Safety and Effectiveness 1.4
| Submitted by: | Phuong Nguyen Son
Regulatory Affairs Specialist | AUG 2 1 2006 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 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: | May 26, 2006 | |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) | |
| Trade or Proprietary
or Model Name: | Procera Titanium Abutment for AstraTech and Cámlog Implant Systems | |
| Legally Marketed Device(s): | Procera Abutment Octagon (K041275)
Procera Abutment Brånemark (K042658)
AstraTech Fixture MicroThread OsseoSpeed (K053384)
Altatec Camlog Screwline Implant System (K022425) | |
Device Description:
Nobel Biocare's Procera Titanium Abutment for AstraTech and Camlog Implant Systems is fabricated to the exact shape, size, and specifications determined in the design process in order to achieve a personalized device that fits precisely, and properly functions, according to each patient's individual needs.
Nobel Biocare's Procera Titanium Abutment for AstraTech and Camlog Implant Systems is similar in design, intended use, and operation to the abutments cleared in predicate devices.
Indications for Use:
Nobel Biocare's Procera Titanium Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Procera Titanium Abutments fit the following endosseous implants:
- -AstraTech 3.5, 4.0, 4.5, 5.0 mm
- -Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2006
Nobel Biocare AB C/O Ms. Phuong Nguyen Son Regulatory Affairs Specialist Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K061478
Trade/Device Name: Procera Titanium Abutment for Astra Tech and Camlog Implant Systems Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 26, 2006 Reccived: May 30, 2006
Dear Ms. Son:
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 cither 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 - Ms. Son
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 CER 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 vour 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,
Chiu Lin, 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
3
510(k) Number (if known):
Device Name: Procera Titanium Abutment for AstraTech and Camlog Implant Systems
Indications For Use:
Nobel Biocare's Procera Titanium Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Procera Titanium Abutments fit the following endosseous implants:
-
AstraTech 3.5, 4.0, 4.5, 5.0 mm
-
Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
× 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 Purge
An Sign-Off)
sion of Anesthesiology, General Hospital,
ion Control, Dental Devices
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