(107 days)
NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
NobelActive Multi Unit Abulments are artificial tooth abutments designed to fit and function on the NobelActive Implants. It is an internal hexagonal design similar to the previous SFB (renamed NobelActive) Abutments. The material of construction is the same as the previous SFB Abutments. The NobelActive Multi Unit Abutments differ from the predicate device in trade name and design.
This document is a 510(k) summary for the NobelActive Multi Unit Abutment. It is a premarket notification for a medical device and therefore does not contain acceptance criteria for device performance in the context of a study, nor does it present the results of a study to demonstrate such performance or discuss any AI components.
The document focuses on:
- Legal Information: Submission details, classification names, trade names, and legally marketed predicate devices.
- Device Description: Material and design differences/similarities to predicate devices.
- Indications for Use: The intended purpose of the device (prosthetic rehabilitation).
- FDA Correspondence: Official letter from the FDA determining substantial equivalence to predicate devices, allowing the device to be marketed.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth, expert information, MRMC studies, or standalone algorithm performance) from the provided text. This type of information is typically found in clinical trial reports, validation studies, or performance testing summaries, which are not part of this 510(k) summary.
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510(k) Summary of Safety and Effectiveness 1.4
| Submitted by: | Kam Leung, Ph.D., RACSenior Regulatory Affairs Specialist |
|---|---|
| Address: | Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887 |
| Telephone: | (714) 282-4800, ext. 7842 |
| Facsimile: | (714) 282-9023 |
| Date of Submission: | September 10, 2007 |
| Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Trade or Proprietaryor Model Name: | NobelActive Multi Unit Abutment |
| Legally Marketed Device(s): | SFB & CFB Angled Abutments (K062749)SFB and CFB Implant System (K061003) |
Device Description:
NobelActive Multi Unit Abulments are artificial tooth abutments designed to fit and function on the NobelActive Implants. It is an internal hexagonal design similar to the previous SFB (renamed NobelActive) Abutments. The material of construction is the same as the previous SFB Abutments. The NobelActive Multi Unit Abutments differ from the predicate device in trade name and design.
Indications for Use:
NobelActive Multi Unit Abutment is a pre-manufactured prosthelic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 8 2007
Nobel Biocare AB C/O Mr. Herbert Crane Director, Global Regulatory Affairs Nobel Biocare, USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K072570
Trade/Device Name: NobelActive Multi Unit Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: NHA Product Code: II Dated: December 5, 2007 Received: December 6, 2007
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.
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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 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 (OS) 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 vours.
Shuli. W. Murphy, MD for Alan Lear, 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
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Indication for Use
510(k) Number (if known): 1072570
Device Name: NobelActive Multi Unit Abutment
Indication For Use:
NobelActive Multi Unit Abutment is a prc-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Stele H. Murphy, 60
(Division Sign-Off)
Division of Anesthasiblogy, General Hospital Infection Control, Dental Devices
Number: K072570
§ 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.)