FDA Registration
Active
🇮🇳 India
PREVEST DENPRO LIMITED
Reg #: 3005628474
·
FEI: 3005628474
·
Expires 2026
Products
15
Proprietary Names
53
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- PREVEST DENPRO LIMITED
- Registration Number
- 3005628474
- FEI Number
- 3005628474
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- EPIP Kartholi, Bari Brahmana, Samba
- City
- Jammu Jammu and Kashmir
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K213244
Owner / Operator
- Firm Name
- Prevest Denpro Limited
- Operator Number
- 10062626
- Address
- Export Promotion Industrial Park
- City
- Bari Brahmana
- State
- Jammu and Kashmir
- Postal Code
- 181133
- Country
- IN
US Agent
- Business Name
- Blackwell Device Consulting
- Contact Name
- Angela Blackwell
- Address
- 16409 Se Division St Ste 216
- City
- Portland
- State
- OR
- ZIP
- 97236
- Country
- US
- [email protected]
- Phone
- 704 4509934
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2020-02-21 |
| Material, Impression | ELW | Class 2 | Dental | No | 2022-12-06 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2022-05-24 |
| Plate, Base, Shellac | EEA | Class 1 | Dental | No | 2020-02-24 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2025-01-05 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2025-01-05 |
| Plaque Disclosing Agent | QJC | Class 1 | Dental | No | 2025-01-27 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2026-04-25 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2020-02-24 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2021-08-02 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2020-02-24 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2023-05-31 |
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 2022-05-24 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2024-03-23 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2025-01-27 |
Proprietary Names
Zitemp
Zinconol
Ziconol XS
Accusil Heavy Body
Accusil Monophase
Accusil Bite Registration
Accusil Light Body
Accusil Putty
Cerafill RCS
Nanoseal S
CalApex
Calplus
Zical Ultra Paste
Zical Ultra Powder / Liquid
Endoseal
Hiflex Shellac Base Plate
Prevest C&B Interim Resin
Prevest C&B Permanent Resin
Prevest C&B Ceramic Resin
Fusion Flo
Fusion Flo SE
Fusion I Seal
Fusion Core DC Flo
Magma NT
Oradox Reveal Caries Revealing Tabs
Rotoflex Blue files
Rotoflex Gold files
Hiflex Modelling Wax
Micron Superior Capsules Shade A1
Micron Superior Shade A1
Micron Bioactive
Micron Luting
Micron Dentin Conditioner
Micron Superior Capsules Shade A3
Micron Superior Capsules Shade A2
Micron Superior Shade A3
Micron Superior Shade A2
Spectra Prophylaxis Paste
Platina Hi-Gloss Composite Polishing Paste
Prevest Burn Out Resin
Prevest Model Resin
Prevest Surgical Guide Resin
CalUltra
Calcigel
Apacal ART
Cal LC
Renew Universal
Renew MDP
Fusion Bond 5
Fusion Bond 7
Fusion Bond DC
Oradox Aligners and Retainers Cleansing Tabs
Oradox Denture Cleansing Tabs
Establishment Types
Manufacture Medical Device