Manufacturer registered with FDA
Prevest Denpro Limited
Bari Brahmana, India. Lists 15 dental device types with FDA across 1 registered establishment, and holds 7 510(k) clearances as applicant.
- Device types listed
- 15
- Brands and models
- 56
- 510(k) clearances
- 72021–2024
- Markets registered in
- 14527 registrations outside the US
- Establishments
- 1India
510(k) clearances per year, 2007–2026
Registered in 14 markets
Where regulators' registries name Prevest Denpro Limited as the manufacturer or the registration holder of a device.
RegisteredHome: IndiaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Prevest Denpro Limited | 7 clearances | 2021–2024 | Below |
| India | CDSCO | Registration holder | Prevest Denpro Limited | 156 | 2022–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | PREVEST DENPRO LIMITED | 139 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Prevest DenPro Limited | 74 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Prevest Denpro Limited | 46 | 2025–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | PREVEST DENPRO LTDPREVEST DENPRO LIMITED · PREVEST DENPRO LTD. | 44 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | PREVEST DENPRO LIMITEDPREVEST DENPRO Ltd. | 25 | 2013–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Prevest DenPro Limited | 20 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | PREVEST DENPRO LIMITED | 13 | 2023–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Prevest Denpro Ltd | 5 | 2007–2023 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Prevest Denpro Limited,Prevest Denpro Ltd. | 2 | 2011–2011 | Pure Global AI |
| Canada | Health Canada | Registration holder | PREVEST DENPRO LIMITED | 1 | 2023–2023 | Pure Global AI |
| Israel | AMAR | Manufacturer | PREVEST DENPRO LIMITED | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Prevest Denpro Limited | 1 | 2015–2015 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Prevest Denpro Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Fusion Core DC FloFusion FloFusion Flo SEFusion I SealMagma NTPrevest C&B Ceramic ResinPrevest C&B Interim ResinPrevest C&B Permanent Resin | 2024 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Prevest C&B Ceramic ResinPrevest C&B Interim ResinPrevest C&B Permanent Resin | 2025 |
| Shellac Base PlateEEA · Class 1 | — | Maker | Hiflex Shellac Base Plate | 2020 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Oradox Aligners and Retainers Cleansing TabsOradox Denture Cleansing Tabs | 2025 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Hiflex Modelling Wax | 2020 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Maker | Apacal ARTCal LCCalcigelCalUltra | 2022 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Platina Hi-Gloss Composite Polishing PasteSpectra Prophylaxis Paste | 2020 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Rotoflex Blue filesRotoflex Gold files | 2026 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | Accusil Bite RegistrationAccusil Heavy BodyAccusil Light BodyAccusil MonophaseAccusil Putty | 2022 |
| Dental CementEMA · Class 2 | Dental cements | Maker | Micron BioactiveMicron Dentin ConditionerMicron LutingMicron Superior Capsules Shade A1Micron Superior Capsules Shade A2Micron Superior Capsules Shade A3Micron Superior Shade A1Micron Superior Shade A2Micron Superior Shade A3 | 2021 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | Ziconol XSZinconolZitemp | 2020 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | CalApexCalplusCerafill RCSEndosealNanoseal SZical Ultra PasteZical Ultra Powder / Liquid | 2022 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Fusion Bond 5Fusion Bond 7Fusion Bond DCRenew MDPRenew Universal | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Prevest Burn Out ResinPrevest Model ResinPrevest Surgical Guide Resin | 2023 |
| Plaque Disclosing AgentQJC · Class 1 | — | Maker | Oradox Reveal Caries Revealing Tabs | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Prevest Denpro Limited as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Nov 2024 | K233273 | C&B Ceramic; C&B Permanent; C&B Interim | EBF Resin Tooth Shade Material |
| 5 Jan 2024 | K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT | EBF Resin Tooth Shade Material |
| 11 Aug 2023 | K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | KLE Resin Tooth Bonding Agent |
| 9 Sep 2022 | K213244 | Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) | ELW Impression Material |
| 23 May 2022 | K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | KIF Root Canal Filling Resin |
| 13 May 2022 | K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | EJK Calcium Hydroxide Cavity Liner |
| 13 May 2021 | K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) | EMA Dental Cement |
Some of these clearances are listed with FDA today by another company: DSI Dental Solutions Ltd (3).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PREVEST DENPRO LIMITEDFDA reg. 3005628474 | Jammu Jammu and Kashmir, India | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062626). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.