K Number
K063554
Device Name
MERON PLUS
Manufacturer
Date Cleared
2007-01-12

(46 days)

Product Code
Regulation Number
872.3275
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
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.
More Information

No
The summary describes a dental cement and does not mention any AI or ML capabilities.

No.
The device is a dental cement intended for permanent cementation of various dental restorations and orthodontic appliances, which is a structural rather than therapeutic function.

No
Explanation: The device is a cement used for permanent bonding of dental restorations, which is a treatment function, not a diagnostic one.

No

The device description clearly states it is a resin reinforced chemically curing glass ionomer cement, which is a physical material, not software.

Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Meron Plus Function: Meron Plus is a dental cement used for the permanent cementation of various dental restorations (crowns, bridges, inlays, etc.) directly onto hard dental tissue. It is a material used in the body, not a device used to test samples from the body.
  • Intended Use: The intended use clearly describes its function as a cement for bonding dental prosthetics, not for diagnostic testing.
  • Device Description: The description focuses on its composition and delivery method as a cement, not on any diagnostic capabilities.
  • Lack of Diagnostic Indicators: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.

Therefore, Meron Plus falls under the category of a dental device used for restorative procedures, not an In Vitro Diagnostic device.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

EMA

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hard dental tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dentist

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K946100

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K062292, K040769, K052820

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

K063554

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

1

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.

2

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

3

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