(82 days)
Amaris® Gingiva Opaquer is intended for use in conjunction with Amaris Gingiva for the following applications:
- for the aesthetic covering and masking of discoloured hypersensitive necks of teeth, especially in the visible anterior area.
- for corrections of the red-white aesthetics.
- for masking and lightening of crown and bridge restorations and margins.
Amaris® gingival shade is a light-curing radiopaque restorative which contains 80% fillers in a methacrylate matrix and which can be cured with blue light. Amaris® gingival shade is used to treat cervical defects and exposed, discoloured or hypersensitive necks of teeth, especially in the visible anterior area. The gingival-like shade and the Amaris® Gingiva Opaquer system allow the correct reproduction of the gingiva in its shade.
The provided text is a 510(k) summary for the medical device "Amaris® Gingiva Opaquer," which is a dental material. This document is a regulatory submission to the FDA, and it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way a diagnostic or therapeutic device might.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory document. The "study" here refers to the rationale for substantial equivalence based on material composition and prior use, not a clinical performance study with statistical endpoints.
Here's an analysis based on the information available in the document:
Analysis of Acceptance Criteria and Device Performance for Amaris® Gingiva Opaquer
This submission primarily demonstrates substantial equivalence for a dental material (Amaris® Gingiva Opaquer) to a previously marketed predicate device (Clearfil ST Opaquer/Kuraray Co. Ltd., K001913). The "acceptance criteria" are implicitly met by demonstrating that the device is of similar technological characteristics and intended use as the predicate, thus implying similar safety and effectiveness. No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this type of device in this document, as it's a material rather than a diagnostic or therapeutic system that typically undergoes such evaluations.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this submission (dental material for substantial equivalence), no specific quantitative "acceptance criteria" or "device performance" metrics (like accuracy, sensitivity, specificity, etc.) are explicitly defined or reported in the provided text. Instead, the acceptance is based on demonstrating:
- Substantial Equivalence: The device is substantially equivalent to a legally marketed predicate device.
- Technological Characteristics: The components are the same as or similar to those in the predicate, supporting similar safety and effectiveness.
- Intended Use: The intended use is comparable to the predicate.
The reported "performance" is an assertion of safety and effectiveness based on the shared components with the predicate device.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Material Composition: All components are found in legally marketed devices. | Met: "All of the components of Amaris® Gingiva Opaquer are found in the legally marketed device Clearfil ST Opaquer/Kuraray Co. Ltd., K001913." |
| Biocompatibility: No additional testing for cytotoxicity, mutagenicity, or biocompatibility is needed due to prior use of components. | Met: "The prior use of all of the components of Amaris® Gingiva Opaquer in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary." |
| Safety and Effectiveness: Demonstrate safety and effectiveness for the intended use. | Met (by assertion of equivalence): "We believe that the prior use of the components of Amaris® Gingiva Opaquer in legally marketed devices and the performance data and results provided support the safety and effectiveness of Amaris® Gingiva Opaquer for the intended use." (The 'performance data and results provided' refers to the basis of substantial equivalence, not a separate clinical performance study with measured outcomes). |
| Intended Use: Device is suitable for aesthetic covering/masking of discoloured hypersensitive necks of teeth, corrections of red-white aesthetics, and masking/lightening of crown/bridge restorations. | Met: The device is stated to be intended for these applications in conjunction with Amaris Gingiva. |
2. Sample size used for the test set and the data provenance
Not applicable for this type of submission. This is a material-based submission for substantial equivalence, not a clinical trial or performance study involving a patient test set. The "data provenance" is indirect, based on the prior regulatory approval and use of the components in the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth was established by experts for a test set in the context of this regulatory submission.
4. Adjudication method for the test set
Not applicable. No test set requiring expert adjudication was described.
5. 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
Not applicable. This device is a dental material, not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental material.
7. The type of ground truth used
Not applicable in the typical sense of a diagnostic or screening device. The "ground truth" for this submission is historical and regulatory: that the components used in the device have a track record of safe and effective use in a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This submission does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned in the provided text.
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510(k) SUMMARY
| Contact: | Manfred Plaumann | |
|---|---|---|
| Date prepared: | March 25th, 2009 | JUN 17 2009 |
| Trade or proprietary name: | Amaris® Gingiva | |
| Classification name: | Material, Tooth Shade, Resin (872.3690) | |
| Predicate device: | Clearfil ST Opaquer/Kuraray Co. Ltd., K001913 |
Device description: Amaris® gingival shade is a light-curing radiopaque restorative which contains 80% fillers in a methacrylate matrix and which can be cured with blue light. Amaris® gingival shade is used to treat cervical defects and exposed, discoloured or hypersensitive necks of teeth, especially in the visible anterior area. The gingival-like shade and the Amaris® Gingiva Opaquer system allow the correct reproduction of the gingiva in its shade.
Intended use:
Amaris® Gingiva Opaquer is intended for use in conjunction with Amaris Gingiva for the following applications:
- for the aesthetic covering and masking of discoloured hypersensitive necks of teeth, ເ especially in the visible anterior area.
- for corrections of the red-white aesthetics.
- for masking and lightening of crown and bridge restorations and margins. -
Technological characteristics: All of the components of Amaris® Gingiva Opaquer are found in the legally marketed device Clearfil ST Opaquer/Kuraray Co. Ltd., K001913.
The prior use of all of the components of Amaris® Gingiva Opaquer in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary. We believe that the prior use of the components of Amaris® Gingiva Opaquer in legally marketed devices and the performance data and results provided support the safety and effectiveness of Amaris® Gingiva Opaquer for the intended use.
VOCO GmbH, March 25th, 2009
VOCO GMBH
Anton Flettner-Str. 1-3
Manfred Plaumann
27472 CUXHAVEN
Managing Board
Germany
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged around the top half of the circular border.
JUN 17 2009
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. T. Gerkensmeier Regulatory Affairs VOCO GmbH Anton-Flettner-Strasse 1-3 D-27472 Cuxhaven GERMANY
Re: K090843
Trade/Device Name: Amaris Gingiva Opaquer Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: June 3, 2009 Received: June 9, 2009
Dear Dr. Gerkensmeier:
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 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 - Dr. Gerkensmeier
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); 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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 yours,
Susan Keane
Susan Runner, D.D.S., M.A Acting 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
510(k) Number: K690843
Amaris® Gingiva Opaquer Device Name:
Indications for Use:
Amaris® Gingiva Opaquer is intended for use in conjunction with Amaris Gingiva for the following applications:
- for the aesthetic covering and masking of discoloured hypersensitive necks of teeth, especially in the visible anterior area.
- for corrections of the red-white aesthetics.
- for masking and lightening of crown and bridge restorations and margins.
Prescription Use X
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rin Muluy Fri MSR
(Division-Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090843
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.