The light-curing one-component dental sealing lacquers NanoVarnish, Plaquit and Lightpaint on Surface are designed for coating resin parts of complete and partial dental prosthesis and for provisional crowns and bridges. The lacquer is applied to a dental restoration and cured with the help of a dental light-curing unit.

AI/ML Overview

This document is a 510(k) premarket notification for a dental sealing lacquer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of AI-powered device performance. Therefore, many of the requested criteria regarding AI acceptance, human readers, and ground truth for AI model training cannot be extracted from this document.

Here's what can be extracted based on the provided text:

Acceptance Criteria and Device Performance

For this type of device (a dental material), "acceptance criteria" are based on demonstrating comparable physical and chemical properties to a legally marketed predicate device, rather than accuracy metrics for an AI system. The study performed is a comparative study of the new device against a predicate device.

Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate: VITA ENAMIC® Glaze K123761)	Reported Device Performance (NanoVarnish, Plaquit, Lightpaint on Surface)
Intended Use	Sealing lacquer for characterization of dental restorations	Dental sealing lacquer for coating resin temporaries
Indications for Use	Final coating for shade customization/characterization, protection from abrasion wear	Varnish for final coating for resin temporaries to produce a smooth and shiny surface
Design	Supplied in glass bottles	Supplied in glass bottles
Chemical Description	One component UV-light curing (meth)acrylic lacquer radical polymerization	One component UV-light curing (meth)acrylic lacquer radical polymerization
Appearance (visual)	Colorless, liquid	Colorless, liquid
Viscosity at 23°C	≤ 0.15	≤ 0.15 - 0.02
Pencil hardness (acc. to Wolff Wilborn)	2 H	2 H
Working / Processing time	< 1 min.	< 1 min.
Curing time	approx. 3 min.	approx. 3 - 5 min.
Temperature	Room temperature	Room temperature
Shelf life	2 years	2 years
Conformance to consensus standards	EN ISO 13485: 2012 + AC:2012, ISO 7405: 2008, ISO 14971: 2007, ISO 10993-1:2009	EN ISO 13485: 2012 + AC:2012, ISO 7405: 2008, ISO 14971: 2007, ISO 10993-1: 2009

Explanation of Differences (as stated in the document): The document explicitly states that "The difference of the Intended Use and the Indications for Use of the Dreve dental sealing lacquers (Plaquit, NanoVarnish and Lightpaint on Surface) and the predicate are due to the availability of the predicate K123761 VITA ENAMIC® Glaze in a set of devices." It clarifies that the Glaze material within the predicate's set is used "for coating purpose only" and provides "protection of the stains from abrasion wear." The document concludes that "The technological characteristics of the subject device and the predicate are virtually identical and both devices have generically the same intended use."

Information NOT available in the document (due to the nature of the device and the submission):

This document describes a conventional medical device (a dental varnish), not an AI/ML-powered device. Therefore, the following information, which is relevant for AI acceptance criteria, is not present and cannot be extracted:

Sample sizes for test set and data provenance: Not applicable. The "study" here is a set of comparable physical and chemical tests, not a clinical trial with patient data or an AI model's test set.
Number of experts and their qualifications for ground truth: Not applicable for a physical material. Ground truth in this context refers to standard measurements/tests.
Adjudication method for the test set: Not applicable.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted human performance studies.
Standalone (algorithm only without human-in-the loop performance): Not applicable as there is no algorithm.
Type of ground truth used: For a physical material, the "ground truth" is established through standardized laboratory testing and material characterization against defined specifications and recognized consensus standards (e.g., ISO standards for dental materials). The document states: "Testing has confirmed these devices meet their product specification."
Sample size for the training set: Not applicable. This document is not about an AI model.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is simple and monochromatic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 5, 2018

Dreve Dentamid Gmbh Reiner Altmann Head Of Quality Management & Regulatory Affairs Max-Planck-Strasse 31 Unna, Norderhein-Westfalen, 59423 DE

Re: K162408

Trade/Device Name: Nano Varnish, Plaquit, Lightpaint On Surface Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material For Resin Fillings Regulatory Class: Class II Product Code: EBD Dated: February 28, 2018 Received: March 5, 2018

Dear Reiner Altmann:

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 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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Mary S. Runner -S

forTina Kiang, Ph.D. 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) K162408

Device Name NanoVarnish Plaquit Lightpaint on Surface

Indications for Use (Describe)

Varnish for final coating for resin temporaries to produce a smooth and shinv surface

Type of Use (Select one or both, as applicable

Z Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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Dreve Dentamid

510(k) Summary

Submitter:	Dreve Dentamid GmbHMax-Planck-Stra e 3159423 Unna / Germany
	Establishment Reg. No. 1000486347
Contact:	Dr. Reiner Altmann(Head of Quality Management &Regulatory Affairs)Phone: +49-2303-8807-0E-mail: reiner.altmann@dreve.de
Official Correspondent:	Mr. Michael Breer(Quality Management Representative)
Date:	April 4th, 2018
510(k) number:	K162408
● Common Name:	Dental sealing lacquer
● Trade/Device Name:	NanoVarnish, Plaquit and Lightpaint on Surface
● Classification Name:	Coating material for resin fillings
● Device Classification:	Class II per 21 CFR 872.3310
● Product Code:	EBO
Primary Predicate Device:	K123761 VITA ENAMIC® Glaze

Device Description

Intended Use:

Dental sealing lacquer for coating resin temporaries

Image /page/3/Picture/7 description: The image is a circular logo with the text "TUV NORD" at the top. Below that is the text "TUV NORD-DUTZ GmbH". The bottom of the logo contains the text "ISO 9001 / ISO 13485". The logo is divided into two halves, with the left half being black and the right half being white.

VDDI
Dental Solutions
German Manufact

ve11'an <lOontlh..indele

Dreve Dentamid GmbH Max-Planck-StraBe 31 59423 Unna/Germany Tel.: +49 2303 8807-0 Fax: +49 2303 8807-55

E-Mail: dentamid@dreve.de Marchetti Sitz:59423 Unna Reg.-Gericht:HammHRB3712

Internet: www.dreve.com/dentamid Lieferadresse: Einsteinstr. 36 Geschaftsfuhrer : Dr. Volker Dreve, Dino

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Dreve Dentamid

Spankasse
Urna Krosse
Blir 43 Kroning Kronika Kronika Kriston Kristikas Kriston Kristikas Klosi Michine Blogi Michine Blogi Michine Blogi Michim Timin Timming Timin Timming 26 44350060
0000043000

Commerzbank AG
Dortmund Kto.-Nr. 03 222
354 00
BLZ 440 800 50
BLZ 440 800 50
BlC: BRESDEFF440
BAN: DE 35 44080050 0322235400

Postbank Dortmund
Kto2-Mr. 6 403 4600
Kto2-Mr. 6 403 4600
BLKIREEFE 0 446 BC:
BAN: DEFE 20 44010046
0006493469

Page 1 of 5

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Indications for Use:

Varnish for final coating for resin temporaries to produce a smooth and shiny surface.

Technological Characteristics

Design

The predicate also includes powder and liquid material for characterization of the surface of dental restorations which is not part of the Dreve dental sealing lacquers. However, the kit also includes VITA ENAMIC® Glaze which is designed to seal and create a smooth and glossy surface same as the Dreve dental sealing lacquers.

The Dreve dental sealing lacquers are the same in respect of design compared to the predicate. Same as the predicate the Dreve light-curing dental sealing lacquers are intended to be applied in-vitro for the purpose of coating dental restorations. They use the same technological characteristics and principles. They are one-component light-curing resins and polymerize by using dental light-curing units.

Material

Same as the predicate the Dreve dental sealing lacquers are based on multifunctional acrylates with photo initiators. The lacquers polymerize in a UV-light initiated free radical addition reaction.

The dental sealing lacquers and the VITA ENAMIC® Glaze are prescription only material. The labeling and working instructions are designed for health care professionals.

Testing

The Dreve dental sealing lacquers have been designed, developed, tested and produced according to ISO 13485, CAN/CSA ISO 13485 and European Medical Device Directive 93/42/EEC. The quality system is certified by a Notified Body.

Testing has confirmed these devices meet their product specification. A series of in-house tests have been conducted to verify the intended signals are accurate and can maintain performance over its useful life. The new device has been also tested in comparison with the predicate and the main characteristics are the same.

Image /page/5/Picture/13 description: The image is a circular logo with the text "TUV NORD" at the top. Below that is the text "TUV NORD CERT GmbH". The outer ring of the circle contains the text "ISO 9001 / ISO 13485". The left side of the circle is black, while the right side is white.

Image /page/5/Picture/14 description: The image shows the text "VDDI Dental Solutions". The text is in a sans-serif font and is black. The words "Dental Solutions" are smaller than the letters "VDDI".

Image /page/5/Picture/15 description: The image shows three letters, B, V, and D, each enclosed in a curved line resembling a parenthesis. Below the letters, there is some text that appears to be a combination of words and symbols. The text includes the words 'Koori' and 'rentallandete' along with other alphanumeric characters and symbols.

Mail: dentamid@dreve.de

Internet: www.dreve.com/dentami Lieferadresse: Einsteinstr. 36 Geschaftsflihrer Dr. Volker Dreve. Dino Marchett Sitz · 59423 Unna Reg.-Gericht: Hamm HRB 3712

Sparkasse Unna
Kto.-Nr. 43 000
BLZ 443 500 60
BIC: WELADED1UNN
IBAN: DE 26 44350060
0000043000

Commerzbank AG Dortmund
Kto.-Nr. 03 222 354 00
BLZ 440 BO0 50
BIC: DRESDEFF440
IBAN: DE 35 44080050
0322235400

Page 2 of 5

Postbank Dortmund
Kto-Nr. 6 493 469
BLZ 440 10046
BIC: PBNKDEFF
IBAN: DE 42 44010046
0006493469

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Substantial Equivalence

Information provided in this application shows that the new device is substantially equivalent to the predicate device in intended use, performance, materials, technological characteristics and application. The differences between these devices are incidental and not significant.

Biocompatibility

An assessment of the biocompatibility according to FDA Recognized Consensus Standard ISO 10993-1 is included in this application. As a result of this assessment/testing we conclude that the device is safe for its intended use and does not raise any new questions compared with the predicate.

Furthermore there are no substantial differences between the Dreve dental sealing lacquers and the predicate device K123761 Vita Enamic® Glaze. In fact, the Dreve dental sealing lacquers and the predicate device are virtually identical. They are the same in function and similar in composition with only minor exceptions.

Harmonized Test

This device is the same (within the definition of design controls) as the device cleared in K123761 - with the addition of qualifying this device to the indicated harmonized standards. This device may be used interchangeably with the predicate.

Summary of the technological characteristics of the new device compared to the predicate:

ComparableParameter	Dental sealing lacquers(NanoVarnish, Plaquit,Lightpaint on Surface)	VITA ENAMIC® GlazeK123761
Intended Use	Dental sealing lacquer forcoating resin temporaries	Sealing lacquer for thesurface characterization ofdental restorations.
Indications for Use	Varnish for final coating forresin temporaries to producea smooth and shiny surface.	VITA ENAMIC® Stains areindicated for shadecustomization andcharacterization of the surfaceof dental restorations made ofhybrid ceramic resin and resinmaterials. The Glaze materialprovided in the Stains setsthe final coating providingprotection of the stains fromabrasion wear.

Image /page/6/Picture/10 description: The image is a circular logo with the text "TUV NORD" at the top. Below that is the text "TON MODO CERT GmbH". The outer ring of the logo contains the text "ISO 9001 / ISO 13485". The logo is divided into black and white sections.

Image /page/6/Picture/11 description: The image contains a logo with the text "VDDI Dental Solutions German Manufacturers" above the word "levlo". Below the word "levlo" is the text "Kooperativ esMitgledim". The image also contains some other symbols and characters that are not easily readable.

eve Dentamid GmbH
Max-Planck-Straße 31
59423 Unna/Germany
Tel.: +49 2303 8807 -0
Fax: +49 2303 8807-55
E-Mail: dentamid@dreve.de

Internet: www.dreve.com/dentamic Lieferadresse: Einsteinstr. 36 eschaftsfOhrer: Dr. Volker Dreve. Dino Marchet Sitz: 59423 Unna Reg -Gericht: Hamm HRB 3712

Sparkasse Unna
Kto.-Nr, 43 000
BLZ 443 500 60
BIC: WELADED1UNN
IBAN: DE 26 44350060
0000043000

Commerzbank AG Dortmund Kto .- Nr. 03 222 354 00 IBAN: DF 35 44080050

age 3 of 5

Postbank Dortmund
Xto.-Nr. 6 493 469
BLZ 440 100 46
BIC: PBNKDEFF
IBAN: DE 42 44010046
006493469

{7}------------------------------------------------

Dreve Dentamid

Design	Supplied in glass bottles.Image: [bottle of liquid]	Supplied in glass bottles.Image: [bottle of liquid]
Chemical description	One component UV-light curing (meth)acrylic lacquer radical pol merization	One component UV-light curing (meth)acrylic lacquer radical ol merization
Appearance visual	Colorless, liquid	Colorless, liquid
Viscosity at 23°C	s; 0.15 - 0.02	s; 0.15
Pencil hardness (acc. to Wolff Wilborn	2 H	2 H
Working / Processin time	< 1 min.	< 1 min.
Curing time	approx. 3 - 5 min.	approx. 3 min.
Tern erature	Room temperature	Room temperature
Shelf life	2 years	2 years
Conformance to consensus standard	EN ISO 13485: 2012 +AC:2012ISO 7405: 2008ISO 14971: 2007ISO 10993-1: 2009	EN ISO 13485: 2012 +AC:2012ISO 7405: 2008ISO 14971: 2007ISO 10993-1:2009

The difference of the Intended Use and the Indications for Use of the Dreve dental sealing lacquers (Plaquit, NanoVarnish and Lightpaint on Surface) and the predicate are due to the availability of the predicate K123761 VITA ENAMIC® Glaze in a set of devices. All components of this set are used for shade customization and characterization of the surface of dental restorations but the VITA ENAMIC® Glaze is for coating purpose only as described in the IFU / The Glaze material provided in the Stains set is the final coating providing protection of the stains from abrasion wear.).

The technological characteristics of the subject device and the predicate are virtually identical and both devices have generically the same intended use.

Conclusion

Image /page/7/Picture/4 description: The image is a circular logo with the text "TUV NORD" at the top. Below that is the text "TUV NORD CERT GmbH". The bottom of the logo contains the text "ISO 9001 / ISO 13485". The left half of the logo is black, while the right half is white.

®
DI

Dental Solutions
German Manufacturers

Image /page/7/Picture/7 description: The image shows the letters B, V, and D in a bold, sans-serif font. The letters are arranged horizontally, with the letter B on the left, V in the middle, and D on the right. There are curved lines above each letter. Below the letters is some text that is difficult to read.

Dreve Dentamid GmhH anck-StraBe 31 E-Mail: dentamid@dreve .de

Internet: www.dreve.com/dentamid Lieferadresse: Einsteinstr. 36 GeschaftsfOhrer: Dr. Volker Dreve, Dino Marchetti Sitz:59423 Unna Req.-Gericht: Hamm HRB 3712

Sparkasse IBAN: DF 26 4435006 000043000

Commerzbank AG Dortmund Kto .- Nr. 03 222 354 00 BI 7 440 BOO 50 IBAN: DE 35 44080050 0322235400

Page 4 of 5

Postbank Dortmund Kto.-Nr. 6 493 469 BI 7 440 10046 RIC: PRNKDFFF IBAN: DE 42 44010046 0006493469

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Dreve dental sealing lacquers are substantially equivalent to the predicate VITA ENAMIC® Glaze based on design, material, performance, technological characteristics and consensus standards.

Dreve Dentamid GmbH

DR EVE-DEI,IT/.\ -/: :n (:; ,11bH Max - Pland - ' : ; u :. ・. :. ・; -1 . Q ?::.0'.J f !:111Z!

4ADr:ReinerAitmann

(Head of Quality Management / Quality Control / Regulatory Affairs & Safety Representative for Medical Devices)

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Dreve Dentamid GmbH Max-Planck-StraBe 31 9423 Unna/Germany Tel.: +49 2303 8807 -0 Fax: +49 2303 8807-55 E-Mail: dentamid@dreve.de Internet: www.dreve.com/dentamid Lieferadresse: Einsteinstr. 36 GeschaftsfOhrer: Dr. Volker Dreve, Dino Marchetti Sitz: 59423 Unna Reg.-Gericht: Hamm HRB 3712

Sparkasse Unna Kto.-Nr. 43 000 BLZ 443 500 60 BIC: WELADED1UNN IBAN: DE 26 44350060 0000043000

Commerzbank AG Dortmund Kto.-Nr. 03 222 354 00 BLZ 440 800 50 BIC: DRESDEFF440 IBAN: DE 35 44080050. 032235400

Page 5 of 5

Postbank Dortmund Kto.-Nr. 6 493 469 BLZ 440 100 46 BIC: PBNKDEFF IBAN: DE 42 44010046 0006493469

Regulation Number and Section

§ 872.3310 Coating material for resin fillings.

(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.