Data / Medical devices / India / Prevest Denpro Limited
Prevest Denpro Limited: FDA-registered device maker in Jammu Jammu and Kashmir, India, 7 510(k) clearances
Prevest Denpro Limited is registered with the FDA (registration 3005628474) in Jammu Jammu and Kashmir, India. It lists 15 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005628474
- Address
- EPIP Kartholi, Bari Brahmana Samba, Jammu Jammu and Kashmir, India, 181133
- Owner or operator
- Prevest Denpro Limited (10062626)
- Roles
- Manufacturer
- First device listed
- February 21, 2020
- Registered through
- 2026
- Brand names listed
- Accusil Bite Registration, Accusil Heavy Body, Accusil Light Body, Accusil Monophase, Accusil Putty, Apacal ART, Cal LC, CalApex and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Manufacturer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Manufacturer | accessdata.fda.gov |
| Liner, Cavity, Calcium Hydroxide | EJK | 2 | Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Plaque Disclosing Agent | QJC | 1 | Manufacturer | accessdata.fda.gov |
| Plate, Base, Shellac | EEA | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Manufacturer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Manufacturer | accessdata.fda.gov |
| Zinc Oxide Eugenol | EMB | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 27, 2024 | K233273 | C&B Ceramic; C&B Permanent; C&B Interim | EBF | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
| January 5, 2024 | K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT | EBF | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
| August 11, 2023 | K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | KLE | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
| September 9, 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 | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
| May 23, 2022 | K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | KIF | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
| May 13, 2022 | K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | EJK | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
| May 13, 2021 | K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) | EMA | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Agent, Tooth Bonding, Resin
- All makers of Wax, Dental, Intraoral
- All makers of Plate, Base, Shellac
- All makers of Resin, Root Canal Filling
- All makers of Material, Impression
- All makers of Plaque Disclosing Agent
Updated November 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.