Prevest Denpro Limited
Jammu Jammu and, IN
PREVEST DENPRO LIMITED appears in FDA device records in Jammu Jammu and, IN. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Prevest Denpro Limited between 2021 and 2024. The busiest year on record is 2022, with 3. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233273 | C&B Ceramic; C&B Permanent; C&B Interim | EBF | Substantially Equivalent | |
| K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT | EBF | Substantially Equivalent | |
| K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | KLE | Substantially Equivalent | |
| 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 | |
| K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | KIF | Substantially Equivalent | |
| K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | EJK | Substantially Equivalent | |
| K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) | EMA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005628474 | 3005628474 | PREVEST DENPRO LIMITED | EPIP Kartholi, Bari Brahmana, Jammu Jammu and Kashmir 181133 IN | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NDPAccessories, Implant, Dental, Endosseous
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KLEAgent, Tooth Bonding, Resin
- EMACement, Dental
- EFTCleanser, Denture, Over The Counter
- EBGCrown And Bridge, Temporary, Resin
- EKSFile, Pulp Canal, Endodontic
- EJKLiner, Cavity, Calcium Hydroxide
- ELWMaterial, Impression
- EBFMaterial, Tooth Shade, Resin
- QJCPlaque Disclosing Agent
- EEAPlate, Base, Shellac
- KIFResin, Root Canal Filling
- EGDWax, Dental, Intraoral
- EMBZinc Oxide Eugenol
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain