(73 days)
No
The description details a physical prosthetic component (an abutment) and its compatibility with specific dental implants. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a prosthetic component used for rehabilitation, not for treatment or therapy.
No
The device is described as a "premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation" and "an artificial tooth abutment." These descriptions indicate it is a replacement part used in restorative procedures, not for identifying a disease or condition.
No
The device description clearly states it is a "premanufactured prosthetic component" and an "artificial tooth abutment," which are physical hardware components. There is no mention of software as the primary or sole component.
No, 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, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Nobel Biocare Multi-Unit Abutment is a "premanufactured prosthetic component" and an "artificial tooth abutment." It is a physical device intended to be implanted and used in the mouth as part of a dental restoration.
- Intended Use: The intended use is "as an aid in prosthetic rehabilitation," which involves replacing missing teeth. This is a clinical procedure performed directly on the patient, not a laboratory test on a sample.
The information provided describes a dental prosthetic device, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
Nobel Biocare's Multi-Unit Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Multi-Unit 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
- Ankylos 3.5, 4.5, 5.5, 7.0 mm
Product codes
NHA
Device Description
Nobel Biocare's Multi-Unit Abutment is an artificial tooth abutment designed to fit and function on the below endosseous implants:
- AstraTech 3.5, 4.0, 4.5, 5.0 mm -
- -Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
- . Ankylos 3.5, 4.5, 5.5, 7.0 mm
The Multi-Unit Abutment is a prosthetic device that fits only the endosseous implants specified. The device has been developed for long-term, permanent use.
Nobel Biocare's Multi-Unit Abutment is similar in design, intended use, and operation to the abultnents 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)
Brånemark System Abutments Complete (K925769)
Reference Device(s)
AstraTech Fixture MicroThread OsseoSpeed (K053384), Altatec Camlog Screwline Implant System (K022425), Ankylos Dental Implant System (K041509)
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: | Ms. Phuong Nguyen Son
Regulatory Affairs Specialist | AUG 11 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: | Multi-Unit Abutments for AstraTech, Camlog, and Ankylos Implant Systems | |
| Legally Marketed Device(s): | Brånemark System Abutments Complete (K925769)
AstraTech Fixture MicroThread OsseoSpeed (K053384)
Altatec Camlog Screwline Implant System (K022425)
Ankylos Dental Implant System (K041509) | |
Device Description:
Nobel Biocare's Multi-Unit Abutment is an artificial tooth abutment designed to fit and function on the below endosseous implants:
- AstraTech 3.5, 4.0, 4.5, 5.0 mm -
- -Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
- . Ankylos 3.5, 4.5, 5.5, 7.0 mm
The Multi-Unit Abutment is a prosthetic device that fits only the endosseous implants specified. The device has been developed for long-term, permanent use.
Nobel Biocare's Multi-Unit Abutment is similar in design, intended use, and operation to the abultnents cleared in predicate devices.
Indications for Use:
Nobel Biocare's Multi-Unit Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Multi-Unit 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
- Ankylos 3.5, 4.5, 5.5, 7.0 mm -
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Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The words are stacked on top of each other, with "Public" on the top line, "Health" on the second line, and "Service" on the third line.
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
AUG 1 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Phuong Nguyen Son Regulatory Affairs Specialist Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K061477
Trade/Device Name: Multi-Unit Abutments for AstraTech, Camlog and Anklos Implant Systems Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 26, 2006 Received: May 30, 2006
Dear Ms. Nguyen 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 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 - Ms. Nguyen 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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Raaser
f. Chi-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
3
Indications for Use
t
K061477 510(k) Number (if known):
Device Name: Multi-Unit Abutments for AstraTech, Camlog and Ankylos Implant Systems
Indications For Use:
Nobel Biocare's Multi-Unit Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Multi-Unit 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
- Ankylos 3.5, 4.5, 5.5, 7.0 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 Russo
Page 1 of 1
...n Sign-Cit)
Han of Anesthesiology, General Hospital,
เอก Control, Dental Devices
Number: Kd6M77
1.3