(71 days)
The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic component directly The Zygonia Angled Abdamont is intended for use as an aid in prosthetic rehabilitation.
The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prostherity in The Nobel Blocare Zygoma Angled Koathent is intended for use as an aid in prosthetic rehabilitation.
The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic The Nobol Elocal o Eygoniant and is intended for use as an aid in prosthetic rehabilitation.
The Zygoma Angled Abutment is an artificial tooth abutment designed to fit and function on Nobel Biocare's Zygoma implant.
The provided text is a 510(k) summary for the "Zygoma Angled Abutments." This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It does not contain information about acceptance criteria for device performance, nor details of a study proving the device meets specific performance metrics.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: The document does not specify any performance-based acceptance criteria or report performance data. It states the device "is intended to be used as a prosthetic component directly" and "is intended for use as an aid in prosthetic rehabilitation," but these are indications for use, not performance metrics.
- Sample size used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
- Adjudication method: No adjudication method is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not an AI device, and no such study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an AI algorithm.
- The type of ground truth used: No ground truth is described.
- The sample size for the training set: No training set is described.
- How the ground truth for the training set was established: No training set ground truth is described.
The document's purpose is to establish substantial equivalence for market clearance, not to demonstrate performance against specific technical criteria through a detailed study summary.
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DEC 2 3 2005
510(k) Summary of Safety and Effectiveness 1.4
| Submitted by: | Herbert CraneDirector, Regulatory Affairs |
|---|---|
| Address: | Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887 |
| Telephone: | (714) 282-5074 |
| Facsimile: | (714) 282-9023 |
| Date of Submission: | November 23, 2005 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietaryor Model Name: | Zygoma Angled Abutments |
| Legally Marketed Devices: | Branemark System 17° Angulated Abutment (K944962) |
Device Description:
Device Description.
The Zygoma Angled Abutment is an artificial tooth abutment designed to fit and function on Nobel Biocare's Zygoma implant.
The Zygoma Angled Abutment is intended to be used as a prosthetic component directly The Zygonia Angled Abdamont is intended for use as an aid in prosthetic rehabilitation.
Indications for Use:
inglications for USE.
The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prostherity in The Nobel Blocare Zygoma Angled Koathent is intended for use as an aid in prosthetic rehabilitation.
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Image /page/1/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2005
Mr. Herbert Crane Regulatory Affairs Director Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K052885
Trade/Device Name: Zygoma Angled Abutments Regulation Number: 872.3630 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: NHA Dated: October 12, 2005 Received: October 20, 2005
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 mensiale commerce prior to may 20, 20, 20, 20, 20, 2011 accordance with the provisions of / Innenthelia, of to arrand Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvial applisions 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 (1 Writ), it may of bacyoo in the Code of Federal Regulations, Title 21. Parts 800 to 898. In your device ear. be fourther 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 Incall that I Dri has made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal bated is requirements, including, but not limited to: registration 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 et read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set fortal in the qualify is a 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) This letter will anow your be objection of substantial equivalence of your device to a premarket notification. - The Pie 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), If you desire specific at no 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 may obtain other generational 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,
Sutte y. Michael Oms.
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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Indications for Use
510(k) Number (if known): K052885
Device Name: Zygoma Angled Abutments
Indications For Use:
indications I or 530.
The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic The Nobol Elocal o Eygoniant and is 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)
Kein Moley for MSR
Page 1 of 1
1.3
§ 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.)