(46 days)
Meron Plus is intended for permanent cementation of porcelain-fused-to metal crowns, bridges on hard dental tissue and cores rebuilt with amalgam, composite or glass ionoms, cements. Meron Plus is further intended for the permanent cementation of metal inlays, onlays, crowns and bridges, posts, crowns manufactured from alumina-only or zirkonia-only cores and orthodontic appliances.
Meron Plus is a resin reinforced chemically curing glass ionomer cement for permanent cementation. It is delivered in bottles for mixing by the dentist as well as in capsules (so called application capsules "AC") for the better handling and ease of use. The device is characterized by high adhesion to tooth structure.
The provided text is a 510(k) summary for Meron Plus, a dental cement. It focuses on demonstrating substantial equivalence to a predicate device based on material composition and prior use of components, rather than providing a detailed study proving device performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and expert involvement is not present in this document.
However, based on the information provided, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided 510(k) document. The document primarily focuses on the substantial equivalence of components to legally marketed devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not available in the provided 510(k) document. The submission states: "The prior use of all of the components Meron Plus in legally marketed devices support our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary." This indicates that the 510(k) did not rely on
new performance testing of the final device but rather on the established performance of its components and predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not available in the provided 510(k) document. Since new performance studies were deemed unnecessary, there would not have been a need for experts to establish ground truth for a test set of the final device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not available in the provided 510(k) document. See point 3.
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:
This information is not applicable and not available in the provided 510(k) document. Meron Plus is a dental cement, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and not available in the provided 510(k) document. Meron Plus is a dental cement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not available in the provided 510(k) document. The submission relies on the established safety and effectiveness of the components and predicate devices through their prior use in legally marketed products.
8. The sample size for the training set:
This information is not available in the provided 510(k) document. This type of information would be relevant for devices that undergo a training phase (e.g., AI algorithms), which is not the case for this dental cement based on the provided document.
9. How the ground truth for the training set was established:
This information is not available in the provided 510(k) document. See point 8.
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Image /page/0/Picture/1 description: The image shows four black shapes against a white background. The shapes appear to be stylized letters, spelling out a word. The first shape resembles an upside-down V, the second and fourth shapes are circles with a smaller circle cut out of the center, and the third shape is a C with a smaller circle cut out of the center.
Anton-Flettner-Straße 1 - 3 27472 Cuxhaven · Germany ഗ്ര +49 4721 719-0 04721 719-109 +49 4721 719-140 www.voco.de info@voco.de
ــﺎ VOCO GmbH · Postfach 7 67 · 27457 Cuxhaven · Germany
JAN 12 26.5
510(k) SUMMARY
Contact: Dr. Süs
Date prepared: November 24, 2006
Trade or proprietary name: Meron Plus
Classification name: Cement, Dental, (872.3275)
Predicate device: Fuji Duet (Fuji Plus), K946100
Meron Plus is a resin reinforced chemically curing glass ionomer Device description: cement for permanent cementation. It is delivered in bottles for mixing by the dentist as well as in capsules (so called application capsules "AC") for the better handling and ease of use. The device is characterized by high adhesion to tooth structure.
Intended use: Meron Plus is intended for permanent cementation of porcelain-fused-to metal crowns, bridges on hard dental thissue and cores rebuilt with amalgam, composite or glass ionomer cements. Meron Plus is further intended for the permanent cementation of metal inlays, only cosse and bridges, posts, crowns manufactured from alumina-only or zirkonia-only cores and orthodontic appliances
Technological
characteristics:
All of the components of Meron Plus are found in the legally marketed devices K946100, K062292, K040769, K052820.
The prior use of all of the components Meron Plus in legally marketed devices support 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 Meron Plus in legally marketed devices and the performance data and results provided support the safety and effectiveness of Meron Pyus for the intended use.
VOQG GmbH, November 24, 2006
Dr. Michael Süs Mgf. for regulatory affairs
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Image /page/1/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 - U.S.A." arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Michael Süs Manager for Regulatory Affairs VOCO GmbH Anton-Flettner-Strasse 1-3 27472 Cuxhaven GERMANY
JAN 1 2 2007
Re: K063554
Trade/Device Name: Meron Plus Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: November 24, 2006 Received: November 27, 2006
Dear Dr. Süs:
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 mey publish further announcements concerning your device in the Federal Register.
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Page 2 – Dr. Michael Süs
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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,
Smite y. M.chan mo.
Chiu S. Lin, PhD
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: K063554
Device Name: Meron Plus
Indications for Use:
Meron Plus is intended for permanent cementation of porcelain-fused-to metal crowns, bridges on hard dental tissue and cores rebuilt with amalgam, composite or glass ionoms, cements. Meron Plus is further intended for the permanent cementation of metal inlays, onlays, crowns and bridges, posts, crowns manufactured from alumina-only or zirkonia-only cores and orthodontic appliances.
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)
Susan Roses
esthesiology, Ger HIG Thinks Co
K6 353-4
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.