(15 days)
Nobel Biocare's Procera® Abutment Octagon is indicated for the treatment of partially edentulous patients requiring prosthetic devices that fit Straumann regular neck 4.8mm endosseous implants in order to restore chewing function.
The Procera® Abutment Octagon is an artificial tooth abutment designed to fit and function on the Straumann Dental Implant System regular neck 4.8mm endosseous implant.
Nobel Biocare's Procera® Abutment Octagon is intended for use in the treatment of partially edentulous patients in order to restore chewing function. The Procera® Abutment Octagon is a prosthetic device that fits only the Straumann regular neck 4.8mm endosseous implant. The device has been developed for long-term, permanent use.
Nobel Biocare's Procera® Abutment Octagon can be made from either titanium or zirconia.
Here's an analysis based on the provided document, addressing your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary for the Procera® Abutment Octagon. For devices approved via the 510(k) pathway, the primary "acceptance criterion" from a regulatory perspective is Substantial Equivalence to a legally marketed predicate device. This means the new device is as safe and effective as a legally marketed device that is not subject to PMA.
The document does not outline specific, quantitative performance acceptance criteria (e.g., strength thresholds, fatigue limits) for the Procera® Abutment Octagon, nor does it present detailed study results with numerical performance metrics against such criteria. This is typical for a 510(k) summary, which focuses on demonstrating equivalence rather than establishing new performance benchmarks.
Instead, the study mentioned (though not explicitly detailed) would have aimed to demonstrate that the new device performs equivalently to the identified predicate devices in its intended use.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (Summary from document) |
|---|---|
| Substantial Equivalence to Predicate Devices (K031719, K971706, K033243) in terms of safety and effectiveness for stated indications. | The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This implies the device's performance, as demonstrated through testing (though not detailed here), was found to be comparable and acceptable. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any test set or the data's provenance (e.g., country of origin, retrospective or prospective). This level of detail is typically found in the full 510(k) submission, not the summary document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the involvement of experts for establishing ground truth for a test set. In the context of dental implants, performance testing often involves mechanical and biocompatibility evaluations rather than interpretation by human experts.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for a test set. This is not applicable given the type of device and the information provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
A MRMC comparative effectiveness study was not done or mentioned. This type of study is typically relevant for interpretative devices (e.g., AI for medical imaging), not for a physical device like a dental abutment. The effectiveness of the abutment would be assessed through mechanical testing and clinical use (post-market surveillance).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical dental abutment, not an algorithm or AI system.
7. The Type of Ground Truth Used
For this type of physical device, "ground truth" would typically be established by:
- Engineering specifications and test standards: Conformance to recognized standards for mechanical strength, fatigue, material properties (e.g., ISO standards for dental implants and components).
- Biocompatibility testing: In vitro and in vivo studies to ensure the materials are safe for use in the human body.
- Clinical performance (implicitly via predicates): The understanding that the predicate devices have a history of safe and effective use provides a baseline for the "ground truth" of performance.
The document does not explicitly state a specific "ground truth" type but implies adherence to safety and effectiveness demonstrated by predicate devices and relevant standards.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical dental abutment, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical dental abutment, not an AI/ML algorithm.
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041275
MAY
- 4 510(k) Summary of Safety and Effectiveness
| Submitted by: | Elizabeth J. MasonSr. Regulatory Affairs Specialist |
|---|---|
| Address: | Nobel Biocare USA Inc.22715 Savi Ranch ParkwayYorba Linda, CA 92887 |
| Telephone: | (714) 282-4800, ext. 7830 |
| Facsimile: | (714) 998-9348 |
| Date of Submission: | May 12, 2004 |
| Classification Name: | Endosseous Implant (21 CFR 872.3640) |
| Trade or Proprietaryor Model Name: | Procera® Abutment Octagon |
| Legally Marketed Device(s): | Esthetic Zirconia Abutment (K031719)TiAdapt Abutment System (K971706)ITI synOcta Meso Abutments (K033243) |
Device Description:
The Procera® Abutment Octagon is an artificial tooth abutment designed to fit and function on the Straumann Dental Implant System regular neck 4.8mm endosseous implant.
Nobel Biocare's Procera® Abutment Octagon is intended for use in the treatment of partially edentulous patients in order to restore chewing function. The Procera® Abutment Octagon is a prosthetic device that fits only the Straumann regular neck 4.8mm endosseous implant. The device has been developed for long-term, permanent use.
Nobel Biocare's Procera® Abutment Octagon can be made from either titanium or zirconia.
Indications for Use:
Nobel Biocare's Procera® Abutment Octagon is indicated for the treatment of partially edentulous patients requiring prosthetic devices that fit Straumann regular neck 4.8mm endosseous implants in order to restore chewing function.
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Performance Standards 1.5
The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and The Glass if Opodar Ucharlor Dulanto Booknown Notertified as applicable to this submission.
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Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
MAY 2 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth J. Mason Senior Regulatory Affairs Specialist Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K041275
Trade/Device Name: Procera® Abutment Octagon Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: May 12, 2004 Received: May 12, 2004
Dear Ms. Mason:
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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinente, of to co, 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 contrely provision 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 Ecderal Register.
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Page 2 -Ms. Mason
Please be advised that FDA's issuance of a substantial equivalence determination does not I foast that FDA has made a determination that your device complies with other requirements modi that 1 Dr may Federal statutes and regulations administered by other Federal agencies. of the Act of ally I odetar statues and sequirements, including, but not limited to: registration Tour must compry with a 807); labeling (21 CFR Part 801); good manufacturing practice alle histing (21 et retri in the quality systems (QS) regulation (21 CFR Part 820); and if requirements 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) rms reter notification. The FDA finding of substantial equivalence of your device to a premarket notification - Free evice 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), 11 you don't be Office of Compliance at (301) 594-4613. 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 of Small Manufacturers, International and Consumer Assistance at its toll-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Olin Liu, 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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510(k) Number (if known):
K0412.75
Device Name: Procera® Abutment Octagon
Indications For Use:
Nobel Biocare's Procera® Abutment Octagon is indicated for the treatment of partially edentulous palients Novel Bloodie of Food as that fit Straumann regular neck 4.8mm endosseous implants in order to restore chewing function.
× 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 Rumps
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number:
Page 1 of 1
1.3
000007
§ 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.)