(44 days)
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures.
The Straumann NN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.
The Straumann NN CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cement-retained or directly veneered.
The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Straumann NN CARES Titanium Abutment and NN CARES Ceramic Abutment:
Summary of Device Acceptance Criteria and Study Findings
The provided 510(k) summary for the Straumann NN CARES Titanium Abutment and NN CARES Ceramic Abutment focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. It does not present a study with specific acceptance criteria and reported device performance metrics in the typical sense of a clinical trial or performance study showing quantifiable outcomes like sensitivity, specificity, accuracy, etc.
Instead, the "acceptance criteria" are implicitly met by demonstrating that the new devices share the same fundamental characteristics as their predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Identical intended use as predicate devices. | "The intended use is identical to the predicate devices." |
| Same material composition as predicate devices. | "The proposed abutments have the same material composition..." |
| Basic design similar to predicate devices. | "...basic design..." (similar to predicates, implied) |
| Fundamental operating principles similar to predicate devices. | "...and fundamental operating principles to the currently cleared devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The submission is based on a comparison of characteristics to predicate devices, not a clinical test set with patient data.
- Data Provenance: Not applicable. There is no test set in the traditional sense of a study involving data from patients or a specific geographic region.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. There is no test set requiring expert ground truth establishment for performance metrics.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no test set for which adjudication would be required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This type of study is not mentioned or implied in the 510(k) summary. The submission focuses on substantial equivalence based on material, design, and intended use, not a comparison of human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Study: No. This device is a physical dental abutment, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of typical software or diagnostic device evaluations. The "ground truth" for this submission is the established legally marketed status and characteristics of the predicate devices. The new devices are deemed "substantially equivalent" if their characteristics match or do not raise new questions of safety or effectiveness compared to the predicates.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a physical dental abutment, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
Conclusion:
This 510(k) submission for the Straumann NN CARES Titanium Abutment and NN CARES Ceramic Abutment falls under the category of substantial equivalence demonstration for a physical device. It does not involve a traditional performance study comparing a device against specific acceptance criteria using a test set with expert-established ground truth, as would be common for diagnostic software or AI-powered devices. The "study" here is the comparison of the new device's characteristics (intended use, material, design, operating principles) to those of legally marketed predicate devices. The FDA's acceptance (clearance) signifies that this comparison demonstrated substantial equivalence.
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Section I 510(k) Summary
1. Applicant's Name and Address
Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 Fax Number: 978-747-0023 Elaine Alan Contact Person: Requlatory Affairs Specialist Date of Submission: September 2, 2008
2. Name of the Device
Trade Name:
Common Name: Classification Name: Regulation Number:
Straumann NN CARES Titanium Abutment Straumann NN CARES Ceramic Abutment Abutment, Dental, Endosseous implants Abutment, Dental, Endosseous implants $872.3630
4. Description of the Device
The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
ર. Intended Use of the Device
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures. The Straumann NN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The abutment is indicated for cement-retained restorations. The Straumann NN CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The abutment is indicated for cemented or directly veneered restorations.
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Technological Characteristics 6.
The proposed abutments are substantially equivalent to the currently cleared devices. The intended use is identical to the predicate devices. The proposed abutments have the same material composition, basic design and fundamental operating principles to the currently cleared devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Institut Straumann AG C/o Ms. Elaine Alan Regulatory Affairs, Specialist Straumann USA 60 Minuteman Road Andover Massachusetts 01810
OCT 1 7 2008
Re: K082545
Trade/Device Name: Straumann NN CARES Titanium Abutment and NN CARES Ceramic Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 2, 2008 Received: September 3, 2008
Dear Ms. Alan:
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 – Ms. Alan
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
Thkmmels-Lendm? for ll
Chiu S. Lin. Ph. D Division 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 Statement
Device Name: Straumann NN CARES Titanium Abutment and NN CARES Ceramic Abutment
Indications for Use:
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures.
The Straumann NN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.
The Straumann NN CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cement-retained or directly veneered.
× 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 (OD
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
510(k) Submission: NN CARES Titanium & Ceramic Abutments September 2, 2008
Straumann US Page 5
§ 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.)