Micron Bioactive Class III and V. Restoration of cervical erosions and root surface caries, Core buildup. Base/Liner Class I, limited Class II, temporary fillings Restoration of primary teeth

Micron Superior Shades A1. A2. A3 Class III, Class V, limited Class I Restoration of primary teeth, Core buildup

Micron Superior Capsules Shades A1, A2, A3 Class III, Class V, limited Class I Restoration of primary teeth, Core buildup

Micron Luting

Base/Liner

Cementation of all types of metal, porcelain fused to metal, and resin crowns, inlays, and bridges Cementation of orthodontic bands Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns

Micron Dentin Conditioner Dentin pre-treatment prior to filling with glass ionomer cement

Device Description

Micron Bioactive is a radiopaque, hydroxyapatite modified-glass ionomer cement.

Micron Superior is a radiopaque glass ionomer cement. It comes in shades A1, A2 and A3.

Micron Superior Capsules is a radiopaque glass ionomer cement. Capsules come in shades A1, A2 and A3.

Micron Luting is a radiopaque, self-curing translucent, particle glass-ionomer luting material.

Micron Dentin Conditioner is a mild polyacrylic acid solution designed to remove the dentinal smear layer and to condition dentine, thus enhancing the bond between glass ionomer cement and the dentine.

AI/ML Overview

The document describes the Prevest Dental Cements, a line of dental materials including Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, and Micron Dentin Conditioner. The acceptance criteria and the study conducted to prove the device meets these criteria are detailed in the "Testing Summary" and comparison tables.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for the Prevest Dental Cements are based on ISO 9917-1. The study reports that all test results met the criteria in Table 1 of ISO 9917-1.

Acceptance Criteria (based on ISO 9917-1)	Reported Device Performance (Prevest Dental Cements)
Appearance of powder and liquid	Met criteria in Table 1 of ISO 9917-1
Opacity	Met criteria in Table 1 of ISO 9917-1
Acid-soluble lead content	Met criteria in Table 1 of ISO 9917-1
Setting time	Met criteria in Table 1 of ISO 9917-1 (Specific values provided for each product type in the comparison tables, e.g., Micron Bioactive: 1:30 – 2 min; Micron Superior: A1 3:30-3:35 min, A2 5:20-5:30 min, A3 3:15-3:20 min; Micron Luting: 2:30 min)
Compressive strength	Met criteria in Table 1 of ISO 9917-1
Film thickness	Met criteria in Table 1 of ISO 9917-1
pH (for Micron Dentin Conditioner)	Met criteria in Table 1 of ISO 9917-1
Shelf life	3 years (Met relevant protocols for physical characteristics)

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only states that "Micron line products were tested" and "Shelf life testing was completed on all devices."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The testing was based on international standards (ISO 9917-1) for physical and chemical properties, not on expert clinical evaluation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable/provided as the testing involved laboratory measurements against a standard, not human adjudication of subjective assessments.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for AI-powered diagnostic devices involving human interpretation, which is not the nature of these dental cements.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable to this device. These are dental cements, not an algorithm or AI system. The "standalone" testing refers to the physical and chemical property tests performed on the materials themselves, without human interpretation as part of the performance metric.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance evaluation of these dental cements is established by the specified physical and chemical properties outlined in ISO 9917-1. These are objective, measurable parameters (e.g., setting time, compressive strength, opacity) for dental materials.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as this is not an AI/ML device that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

May 13, 2021

Prevest Denpro Limited % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030

Re: K200555

Trade/Device Name: Prevest Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: February 2, 2021 Received: February 12, 2021

Dear Angela Blackwell:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Michael Adjodha Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200555

Device Name

Prevest Dental Cements (Micron Bioactive, Micron Superior Capsules, Micron Luting and Micron Dentin Conditioner)

Indications for Use (Describe)

Micron Bioactive Class III and V. Restoration of cervical erosions and root surface caries, Core buildup. Base/Liner Class I, limited Class II, temporary fillings Restoration of primary teeth

Micron Superior Shades A1. A2. A3 Class III, Class V, limited Class I Restoration of primary teeth, Core buildup

Micron Superior Capsules Shades A1, A2, A3 Class III, Class V, limited Class I Restoration of primary teeth, Core buildup

Micron Luting

Base/Liner

Micron Dentin Conditioner Dentin pre-treatment prior to filling with glass ionomer cement

Type of Use (Select one or both, as applicable)

X 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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Prevest DenPro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting and Micron Dentin Conditoner) 510K Summary K200555 May 10, 2021

Name and Address: Prevest Denpro Limited Export Promotion Industrial Park Bari Brahmana, Jammu 181133 India Contact Person: Atul Modi Email: prevestindia@gmail.com Telephone: (941) 919 4280

Name of device: Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, and Micron Dentin Conditioner) Classification Name: dental cement CFR: 21 CFR 872.3275 Primary Product Code: EMA

Submission Contact:

Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com

Device Description:

Micron Bioactive is a radiopaque, hydroxyapatite modified-glass ionomer cement.

Micron Superior is a radiopaque glass ionomer cement. It comes in shades A1, A2 and A3.

Micron Superior Capsules is a radiopaque glass ionomer cement. Capsules come in shades A1, A2 and A3.

Micron Luting is a radiopaque, self-curing translucent, particle glass-ionomer luting material.

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Indications for Use:

Device Name	Indications
Micron Bioactive	Class III and V,Restoration of cervical erosions and root surfacecaries,Core buildup,Base/LinerClass I, limited Class II, temporary fillingsRestoration of primary teeth
Micron Superior	Class III, Class V, limited Class IRestoration of primary teeth,Core buildup
Micron Superior Capsules	Class III, Class V, limited Class IRestoration of primary teeth,Core buildup
Micron Luting	Cementation of all types of metal, porcelainfused to metal, and resin crowns, inlays, onlays,and bridgesCementation of orthodontic bandsCementation of stainless steel crowns ororthodontic appliances retained with stainlesssteel crownsBase/Liner
Micron Dentin Conditioner	Dentin pre-treatment prior to filling with glassionomer cement

Testing Summary:

Micron line products were tested for appearance of powder and liquid, opacity, acidsoluble lead content, setting time, compressive strength, and film thickness according to protocols based on ISO 9917-1 as was appropriate for each material. pH was tested for Micron Dentin Conditioner.

Shelf life testing was completed on all devices using relevant protocols also used for the physical characteristics tested.

All tests results met the criteria in Table 1 of ISO 9917-1.

The dental cements contain ingredients found in the predicate and reference devices so no biocompatibility testing was done.

Primary Predicate Device: ProGlass Cements K101869 from Silmet

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Reference Devices: Teethmate K131068 from Kuraray Ketac Conditioner K872984 from ESPE GMBH Riva Luting Capsules K040393 from Southern Dental Industries GlasIonomer FX-2 K031467 from Shofu

Substantial Equivalence:

The acid-base cements have similar ingredients to the predicate and reference devices, the same indications for use, and similar physical parameter testing protocols based on ISO 9917-1. Shelf life testing was also similar to the predicate device shelf life testing.

	Subject Device	Predicate Device	Reference Device for additional indications	Reference Device for Hydroxyapatite ingredient	Reference Device for Ingredients
Name	Micron Bioactive	ProGlass TwoK101869	ProGlass SilverK101869	TeethmateK131068	Glaslonomer FX-2K031467
Indications for Use	Class III and V, Restoration of cervical erosions and root surface caries, Core buildup, Base/Liner Class I, limited Class II, temporary fillings Restoration of primary teeth	Class III and V, Restoration of cervical erosions and root surface caries, Core buildup, Base/Liner	Class I, limited Class II, temporary fillings Restoration of primary teeth, Core buildup, Base/Liner	TEETHMATE DESENSITIZER is indicated for reduction of tooth hypersensitivity by the following treatments: [ 1 ] Treatment of dentin exposed by toothbrush abrasion, gingival recession, periodontal disease and/or acid erosion [2] Treatment of dentin after mechanical tooth cleaning, scaling and/or root planing [3] Treatment of tooth surface before and/ or after bleaching	Glasionomer FX-II is a glass polyalkenoate cement used for dental restorations Glasionomer FX-II is intended for use as a final restorative for deciduous teeth; a geriatric restorative for Class I, II, III and V cavities and cervical erosions; a final restorative for Class I and II of adult dentition in non-load bearing situations; an intermediate restorative for heavy stress cavities; a core build up; and for pit and fissure fillings.

Dental Cements from Prevest Denpro Micron Line

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				[4] Treatmentof prepareddentin forfillings and/orprostheticrestorations
Composition	PowderFluoroaluminosilicateglass powder andhydroxyapatitepowderLiquidPolyacrylic acidsolution	PowderAlumino-silicateglass andsilverLiquidPolyacrylicacid	PowderAlumino-silicateglass andsilverLiquidPolyacrylicacid	Hydroxyapatite	Powder:Fluoroaluminosilicateglass, pigments andfluorescent materialLiquid: Acrylic acidtri-carboxylic acid co-polymer solution,tartaric acidCocoa butter: Cocoabutter, whitevaseline
Setting Time	1:30 – 2 min	3:10 min	4 min	N/A	2:30 min

	Subject Device	Predicate Device	Reference Device forIngredients
Name	Micron Superior	ProGlass TwoK101869	Glasionomer FX-2K031467
Indications for Use	Class III, Class V, limitedClass IRestoration of primaryteeth,Core buildup	Class III, Class V,limited Class IRestoration ofprimary teeth,Core buildup	Glasionomer FX-II isa glass polyalkenoatecement used fordental restorationsGlasionomer FX-II isintended for use as afinal restorative fordeciduous teeth;a geriatric restorativefor Class I, II, III andV cavities andcervical erosions; afinal restorative forClass I and II ofadult dentition innon-load bearingsituations; anintermediaterestorative for heavystress cavities; a corebuild up;

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			and for pit andfissure fillings.
Composition	PowderFluoroaluminosilicateglass powderLiquidPolyacrylic acid	PowderAlumino-silicateglass and polyacrylicacidLiquidPolyacrylic acid anddistilled water	Powder:Fluoroaluminosilicateglass, pigments andfluorescent materialLiquid: Acrylic acidtri-carboxylic acid co-polymer solution,tartaric acidCocoa butter: Cocoabutter, whitevaseline
Setting Time	A1 3:30-3:35 minA2 5:20-5:30 minA3 3:15-3:20 min	3:10 min	2:30 min

	Subject Device	Predicate Device	Reference Device forIngredients
Name	Micron Superior Capsules	ProGlass TwoK101869	Riva Luting CapsulesK040393
Indications for Use	Class III, Class V, limitedClass IRestoration of primaryteeth,Core buildup	Class III, Class V,limited Class IRestoration ofprimary teeth,Core buildup	Suitable forcementation ofcrowns,bridges, inlays andorthodonticbands.Also suitable forsealing interfacebetween restorationand tooth andbase / liner in deeprestorations.
Composition	PowderFluoroaluminosilicateglass powderLiquidPolyacrylic acid	PowderAlumino-silicateglass and polyacrylicacidLiquidPolyacrylic acid anddistilled water	PowderFluoro AluminosilicateGlassPolyacrylic AcidLiquidPolyacrylic acidTartaric Acidwater
Working Time	1:30 min	1:30-2 min	unknown
Setting Time	A1 3:30-3:35 minA2 5:20-5:30 minA3 3:15-3:20 min	3:10 min	unknown

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	Subject Device	Predicate Device	Reference Device for Ingredients
Name	Micron Luting	ProGlass OneK101869	Glaslonomer FX-2K031467
Indications for Use	Cementation of all typesof metal, porcelain fusedto metal, and resincrowns, inlays, onlays,and bridgesCementation oforthodontic bandsCementation of stainlesssteel crowns ororthodontic appliancesretained with stainlesssteel crownsBase/Liner	Cementation of alltypes of metal,porcelain fused tometal, and resincrowns, inlays,onlays, and bridgesCementation oforthodontic bandsCementation ofstainless steelcrowns ororthodonticappliances retainedwith stainless steelcrownsBase/Liner	Glasionomer FX-II isa glass polyalkenoatecement used fordental restorationsGlasionomer FX-II isintended for use as afinal restorative fordeciduous teeth;a geriatric restorativefor Class I, 11, III andV cavities andcervical erosions; afinal restorative forClass I and 11 ofadult dentition innon-load bearingsituations; anintermediaterestorative for heavystress cavities; a corebuild up;and for pit andfissure fillings.
Composition	PowderFluoroaluminosilicateglass powderLiquidPolyacrylic acid with thinviscosity	PowderAlumino-silicateglass and polyacrylicacidLiquidPolyacrylic acid anddistilled water	Powder:Fluoroaluminosilicateglass, pigments andfluorescent materialLiquid: Acrylic acidtri-carboxylic acid co-polymer solution,tartaric acidCocoa butter: Cocoabutter, whitevaseline
Setting Time	2:30 min	3:10 min	2:30 min

	Subject Device	Predicate Device
Name	Micron DentinConditioner	Ketac ConditionerK872984
	Indications for Use	Dentin pre-treatmentprior to filling with glassionomer cement

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Composition	Polyacrylic acid solution	Polyacrylic acid solution
-------------	---------------------------	---------------------------

Shelf life testing for all 5 devices is 3 years (testing for two devices was done on each of 3 shades) and used the same physical parameters protocols as the testing. This is the same type of protocols as the shelf life testing for the predicate devices from Silmet but the current shelf life of those devices is unknown.

Conclusion: Prevest Denpro Powder/Liquid Acid-Base dental cements are substantially equivalent to the predicate devices, ProGlass. They have the same indications, similar testing (including shelf life testing), and very similar ingredients. Both the subject devices and the predicate devices have setting times which meet requirements of ISO 9917-1 Table 1 for the respective type of cement. Reference devices are included to cover any ingredients, or indications not covered by the predicate devices. Any differences in ingredients are minor and do not change the substantial equivalence.

Regulation Number and Section

§ 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.