(151 days)
The NobelProcera Angulated Screw Channel Abutment Replace are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Nobel Biocare's NobelProcera Anquiated Screw Channel Abutment Replace is an endosseous dental implant abutment. The abutment attaches directly to Nobel Biocare dental implants with a conical connection and provides a platform for restoration.
Nobel Biocare's NobelProcera Angulated Screw Channel Abutment Replace is designed and made individually to fit the individual requirements for each patient. The abutments are a two piece design with an adapter portion made of titanium vanadium alloy and an abutment portion made of zirconium oxide. The screw channel can be angulated between 0° and 25° as required.
The provided text describes the 510(k) submission for the "NobelProcera Angulated Screw Channel Abutment Replace". This is a medical device clearance submission, not a study evaluating a diagnostic device or an AI algorithm. Therefore, many of the requested elements for describing a study on acceptance criteria and device performance (e.g., sample size, expert ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this document.
However, I can extract the relevant information regarding the device's acceptance criteria and how compliance was demonstrated for this type of medical device clearance.
Here's a breakdown based on the provided text, focusing on the available information:
Description of Acceptance Criteria and Device Performance for NobelProcera Angulated Screw Channel Abutment Replace
This document describes the 510(k) submission for the NobelProcera Angulated Screw Channel Abutment Replace, an endosseous dental implant abutment. The acceptance criteria for this type of device primarily revolve around demonstrating substantial equivalence to a legally marketed predicate device and meeting specific performance standards, mainly fatigue testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied from the document) | Reported Device Performance/Compliance |
|---|---|---|
| Substantial Equivalence | Demonstrate similarity in design, construction, anatomical site, platform compatibility, screw channel, device material, and indications for use to a predicate device. | The submission claims "The information provided in this submission demonstrates that the device is substantially equivalent to the predicate device." |
| Predicate Device | Nobel Biocare - Esthetic Zirconia Abutment (K031719) | The new device and predicate device have similarities as outlined in the "Comparison of Technological Characteristics" table. Differences (e.g., variable vs. fixed screw channel, different material for implant adapter vs. whole abutment) were deemed not to raise new questions of safety or effectiveness. |
| Fatigue Testing | Compliance with FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." | "Non-clinical test data was used to support the decision of safety and effectiveness. Clinical testing was not necessary. Non-clinical testing consisted of performance of fatigue testing in accordance with the FDA guidance..." |
| Biocompatibility | (Not explicitly stated, but implied for an implantable device) | (Information not provided in the excerpt, but typically required for such devices) |
| Labeling | Accurate and not misleading, and adherence to "Indications for Use" statement. | The Indications for Use statement is provided and is part of the submission reviewed by FDA. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This document does not describe a "test set" in the context of a diagnostic algorithm or clinical trial. The testing primarily involved non-clinical fatigue testing. The specific number of abutments subjected to fatigue testing is not provided in this excerpt.
- Data Provenance: The testing was "non-clinical" and involved in-vitro fatigue testing as per FDA guidance. The provenance is internal testing conducted by Nobel Biocare or a contracted lab. The document does not specify a country of origin for the "data" itself, but the applicant (Nobel Biocare AB) is based in Sweden.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This is not a study requiring expert ground truth for a diagnostic outcome. The "ground truth" for fatigue testing is defined by the physical failure criteria outlined in the relevant FDA guidance document for dental implants and abutments.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical study or human-based assessment requiring an adjudication method. The evaluation was based on objective mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical component, not a diagnostic tool where human readers assess cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical medical component, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for demonstrating safety and effectiveness was primarily based on compliance with a regulatory guidance document for mechanical fatigue testing (Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments). This guidance typically specifies load levels, cycles to failure, and other mechanical performance metrics that devices must meet.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML or diagnostic device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
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APR 0 4 2014
510(k) Summary 1.4
| Submitted by: | Phuong NguyenSenior Regulatory Affairs ManagerNobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887 |
|---|---|
| Submitted for: | Nobel Biocare ABVastra Hamngatan 1Goteborg, SE 411 17Sweden |
| Telephone: | (714) 282-4800 x7830 |
| Facsimile: | (714) 998-9348 |
| Date of Submission: | November 1, 2013 |
| Classification Name:Pro Code: | Endosseous Dental Implant Abutment (21 CFR 872.3630)NHA |
| Trade or Proprietaryor Model Name: | NobelProcera Angulated Screw Channel Abutment Replace |
Legally Marketed Devices: Nobel Biocare - Esthetic Zirconia Abutment (K031719)
Device Description:
Nobel Biocare's NobelProcera Anquiated Screw Channel Abutment Replace is an endosseous dental implant abutment. The abutment attaches directly to Nobel Biocare dental implants with a conical connection and provides a platform for restoration.
Nobel Biocare's NobelProcera Angulated Screw Channel Abutment Replace is designed and made individually to fit the individual requirements for each patient. The abutments are a two piece design with an adapter portion made of titanium vanadium alloy and an abutment portion made of zirconium oxide. The screw channel can be angulated between 0° and 25° as required.
Indications for Use:
The NobelProcera Angulated Screw Channel Abutment Replace are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Summary of testing to demonstrate safety and effectiveness
Non-clinical test data was used to support the decision of safety and effectiveness. Clinical testing was not necessary. Non-clinical testing consisted of performance of fatigue testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
Nobel Biocare Traditional 510(k) Notification NobelProcera ASC Abutments Rpl November 2013
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omparison of Technological Characteristics
.
| ATTRIBUTE | CANDIDATE | PREDICATE |
|---|---|---|
| Design/ construction | Nobel Procera Angulated Screw Channel AbutmentReplace | Esthetic Zirconia Abutment (K031719) |
| Patient specific / machined | Patient specific / machined | |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Platform compatibility | Nobel Biocare- Replace | Nobel Biocare- Branemark- Replace |
| Screw Channel | Variable 0° to 25° | Fixed 0° |
| Device Material | Implant Adapter- Titanium/vanadium alloy | Zirconium oxide |
| Indications for Use | The NobelProcera Angulated Screw Channel AbutmentReplace are premanufactured prosthetic componentsdirectly connected to endosseous dental implants and areintended for use as an aid in prosthetic rehabilitation. | Nobel Biocare's Esthetic Zirconia Abutment is indicated forthe treatment of partially edentulous patients requiringprosthetic devices and/or endosseous implants to restorechewing function. |
Conclusion
·
Conclusion
The information provided in this submission demonstrates that the device is substantially equivalent to the predicate device
Nobel Biocare Traditional 510(k) Notification
NobelProcera ASC Abutments Rpl
November 2013
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2014
Nobel Biocare AB C/O Phuong Nguyen Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Re: K133377
Trade/Device Name: NobelProcera Angulated Screw Channel Abutment Replace Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 25, 2014 Received: March 5, 2014
Dear Ms. Nguyen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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 or any I outlar states and the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Ms. Nguyen
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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): ךךך 333
Device Name: NobelProcera Angulated Screw Channel Abutment Replace
Indications For Use:
The NobelProcera Angulated Screw Channel Abutment Replace are premanufactured prosthetic components directly connected to endosseous dental implants and are 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)
Sheena A. Greer 2014.04.02 15:03:28 -04'00'
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§ 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.)