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

Q: Who is the manufacturer of Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)?

Prevest Denpro Limited filed the 510(k) submission for Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) (K200555).

Q: What is the FDA product code for Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)?

EMA. It is classified under 21 CFR 872.3275 as a Class 2 device in the Dental panel.

Q: What is the regulatory pathway for Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K200555 · Prevest Denpro Limited · EMA · May 13, 2021 · Dental

Device Facts

Record ID	K200555
Device Name	Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)
Applicant	Prevest Denpro Limited
Product Code	EMA · Dental
Decision Date	May 13, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3275
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

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 Story

Prevest Dental Cements (Micron line) are radiopaque, self-curing glass ionomer cements and a dentin conditioner. Used by dental professionals in clinical settings for restorative procedures, cementation of prosthetics/orthodontic appliances, and cavity lining. Micron Bioactive incorporates hydroxyapatite; Micron Superior and Luting are fluoroaluminosilicate glass-based. Micron Dentin Conditioner is a polyacrylic acid solution for smear layer removal. Materials are mixed (powder/liquid or capsules) and applied to tooth structures. Cements harden via acid-base reaction. Output is a restorative or luting material that bonds to dentin/enamel, providing structural support, sealing, or retention for dental prosthetics. Benefits include restoration of tooth function, caries management, and prosthetic stability.

Clinical Evidence

Bench testing only. Testing included appearance, opacity, acid-soluble lead content, setting time, compressive strength, and film thickness per ISO 9917-1. Shelf life testing was performed for all devices. No clinical data or biocompatibility testing was required as ingredients are found in legally marketed predicate and reference devices.

Technological Characteristics

Materials: Fluoroaluminosilicate glass powder, hydroxyapatite, polyacrylic acid solution. Principle: Acid-base reaction (self-curing). Standards: ISO 9917-1. Form factor: Powder/liquid or capsules. Sterilization: Not specified.

Indications for Use

Indicated for dental restorations including Class I, II, III, and V cavities, cervical erosions, root surface caries, core buildup, base/liner, temporary fillings, and restoration of primary teeth. Also indicated for cementation of crowns, bridges, inlays, onlays, orthodontic bands, and stainless steel crowns, and for dentin pre-treatment.

Regulatory Classification

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. 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.

Predicate Devices

ProGlass Cements (K101869)

Reference Devices

Teethmate (K131068)
Ketac Conditioner (K872984)
Riva Luting Capsules (K040393)
GlasIonomer FX-2 (K031467)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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 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 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. {3}------------------------------------------------ ## 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. 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. {4}------------------------------------------------ #### Indications for Use: | Device Name | Indications | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 | Class III, Class V, limited Class I Restoration of primary teeth, Core buildup | | Micron Superior Capsules | Class III, Class V, limited Class I Restoration of primary teeth, Core buildup | | Micron Luting | Cementation of all types of metal, porcelain fused to metal, and resin crowns, inlays, onlays, and bridges Cementation of orthodontic bands Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns Base/Liner | | Micron Dentin Conditioner | Dentin pre-treatment prior to filling with glass ionomer 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 {5}------------------------------------------------ ### 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 Two K101869 | ProGlass Silver K101869 | Teethmate K131068 | Glaslonomer FX-2 K031467 | | 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 {6}------------------------------------------------ | | | | | [4] Treatment of prepared dentin for fillings and/or prosthetic restorations | | |--------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Composition | Powder Fluoroaluminosilicate glass powder and hydroxyapatite powder Liquid Polyacrylic acid solution | Powder Alumino- silicate glass and silver Liquid Polyacrylic acid | Powder Alumino- silicate glass and silver Liquid Polyacrylic acid | Hydroxyapatite | Powder: Fluoroaluminosilicate glass, pigments and fluorescent material Liquid: Acrylic acid tri-carboxylic acid co- polymer solution, tartaric acid Cocoa butter: Cocoa butter, white vaseline | | Setting Time | 1:30 – 2 min | 3:10 min | 4 min | N/A | 2:30 min | | | Subject Device | Predicate Device | Reference Device for Ingredients | |---------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Micron Superior | ProGlass Two K101869 | Glasionomer FX-2 K031467 | | Indications for Use | Class III, Class V, limited Class I Restoration of primary teeth, Core buildup | Class III, Class V, limited Class I Restoration of primary teeth, Core buildup | 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; | {7}------------------------------------------------ | | | | and for pit and fissure fillings. | |--------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Composition | Powder Fluoroaluminosilicate glass powder Liquid Polyacrylic acid | Powder Alumino-silicate glass and polyacrylic acid Liquid Polyacrylic acid and distilled water | Powder: Fluoroaluminosilicate glass, pigments and fluorescent material Liquid: Acrylic acid tri-carboxylic acid co- polymer solution, tartaric acid Cocoa butter: Cocoa butter, white vaseline | | Setting Time | A1 3:30-3:35 min A2 5:20-5:30 min A3 3:15-3:20 min | 3:10 min | 2:30 min | | | Subject Device | Predicate Device | Reference Device for Ingredients | |---------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Micron Superior Capsules | ProGlass Two K101869 | Riva Luting Capsules K040393 | | Indications for Use | Class III, Class V, limited Class I Restoration of primary teeth, Core buildup | Class III, Class V, limited Class I Restoration of primary teeth, Core buildup | Suitable for cementation of crowns, bridges, inlays and orthodontic bands. Also suitable for sealing interface between restoration and tooth and base / liner in deep restorations. | | Composition | Powder Fluoroaluminosilicate glass powder Liquid Polyacrylic acid | Powder Alumino-silicate glass and polyacrylic acid Liquid Polyacrylic acid and distilled water | Powder Fluoro Aluminosilicate Glass Polyacrylic Acid Liquid Polyacrylic acid Tartaric Acid water | | Working Time | 1:30 min | 1:30-2 min | unknown | | Setting Time | A1 3:30-3:35 min A2 5:20-5:30 min A3 3:15-3:20 min | 3:10 min | unknown | {8}------------------------------------------------ | | Subject Device | Predicate Device | Reference Device for Ingredients | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Micron Luting | ProGlass One K101869 | Glaslonomer FX-2 K031467 | | Indications for Use | Cementation of all types of metal, porcelain fused to metal, and resin crowns, inlays, onlays, and bridges Cementation of orthodontic bands Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns Base/Liner | Cementation of all types of metal, porcelain fused to metal, and resin crowns, inlays, onlays, and bridges Cementation of orthodontic bands Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns Base/Liner | 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, 11, III and V cavities and cervical erosions; a final restorative for Class I and 11 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. | | Composition | Powder Fluoroaluminosilicate glass powder Liquid Polyacrylic acid with thin viscosity | Powder Alumino-silicate glass and polyacrylic acid Liquid Polyacrylic acid and distilled water | Powder: Fluoroaluminosilicate glass, pigments and fluorescent material Liquid: Acrylic acid tri-carboxylic acid co- polymer solution, tartaric acid Cocoa butter: Cocoa butter, white vaseline | | Setting Time | 2:30 min | 3:10 min | 2:30 min | | | Subject Device | Predicate Device | |------|------------------------------|-----------------------------------------------------------------------| | Name | Micron Dentin Conditioner | Ketac Conditioner K872984 | | | Indications for Use | Dentin pre-treatment prior to filling with glass ionomer cement | {9}------------------------------------------------ | 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.

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

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Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

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

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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