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Sign in to claim this brandPREVEST DENPRO LIMITED
US
Last updated May 25, 2026
What PREVEST DENPRO LIMITED makes
Prevest Denpro Limited manufactures dental materials including calcium hydroxide and glass ionomer cements for cavity treatment, composite resins for crowns, bridges, and restorations, and dental impression and fabrication resins. Their portfolio also covers dentifrice (toothpaste) formulations, temporary crown/bridge resins, and materials for dental appliance fabrication. Additional products include composite dental impression materials and specialized resins for 3D-printed surgical guides.
The company’s devices are regulated under FDA Class I and Class II classifications, with submissions recorded in the FDA’s 510(k) and UDI registries. These materials are intended for dental applications and comply with U.S. medical device regulations. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of dental materials does Prevest Denpro Limited manufacture?
Prevest Denpro Limited specializes in dental materials used for restorative, preventive, and prosthetic applications. Their portfolio includes calcium hydroxide and glass ionomer cements for cavity treatment, composite resins for crowns, bridges, and restorations, as well as dental impression and fabrication resins. They also produce dentifrice (toothpaste), temporary crown/bridge resins, and materials for dental appliance fabrication, such as 3D-printed surgical guides. These products are designed to meet clinical needs in dental procedures.
Where is Prevest Denpro Limited based, and what does that mean for their regulatory oversight?
Prevest Denpro Limited is based in the United States, which means their devices are subject to U.S. medical device regulations. Since dental materials fall under FDA oversight, their products are classified under Class I (generally low-risk) or Class II (moderate-risk, requiring special controls). This classification determines the regulatory pathway, such as 510(k) premarket notifications for Class II devices, ensuring compliance with safety and effectiveness standards before market entry.
Which regulatory registries list Prevest Denpro Limited’s devices, and why does that matter?
Prevest Denpro Limited’s devices are recorded in the FDA’s 510(k) and Unique Device Identifier (UDI) registries—two key databases for tracking authorized medical devices in the U.S. The 510(k) registry confirms that Class II devices have undergone premarket review to demonstrate substantial equivalence to predicate devices, while the UDI system ensures traceability and transparency in the supply chain. Listing in these registries helps healthcare providers verify compliance and identify authorized products.
How are Prevest Denpro Limited’s dental materials classified under FDA regulations?
Prevest Denpro Limited’s devices are classified as Class I or Class II under FDA regulations. Class I typically includes low-risk materials like some dental cements or impression resins, which generally require only general controls (e.g., good manufacturing practices). Class II applies to higher-risk products like composite resins or temporary crown/bridge materials, which may require 510(k) clearance to demonstrate safety and effectiveness through clinical or performance testing against a legally marketed predicate device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 859546940
Catalogue (150)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Renew Universal | Regular Pack | FDA UDI | Class II | Active |
| Accusil Combo Kit Putty + Light Body (Soft) | 150ml putty 50ml Light Body | FDA UDI | Class II | Active |
| Calcigel | Intro Pack | FDA UDI | Class II | Active |
| ApaCal ART | Intro Pack | FDA UDI | Class II | Active |
| CalApex | 20g | FDA UDI | Class II | Active |
| Zical Ultra Automix Paste | 15g | FDA UDI | Class II | Active |
| CalApex Manual Mix Paste | 20g | FDA UDI | Class II | Active |
| Cerafill RCS | Trial Pack | FDA UDI | Class II | Active |
| Accusil Bite Registration | Regular Set / Fast Set 1 x 50ml | FDA UDI | Class II | Active |
| Magma NT | Refill Pack | FDA UDI | Class II | Active |
| Cerafill RCS | Regular Pack in Box | FDA UDI | Class II | Active |
| Accusil Heavy Body | Fast Set 1 x 50ml | FDA UDI | Class II | Active |
| Accusil Light Body | Intro Pack | FDA UDI | Class II | Active |
| Fusion Flo | Intro Pack | FDA UDI | Class II | Active |
| Accusil Monophase | Fast Set 2 x 50ml | FDA UDI | Class II | Active |
| Cerafill RCS | Regular Pack in Plastic Bag | EUDAMEDFDA UDI | Class II | Active |
| Spectra Fresh Pineapple | Intro Pack 75g jar | FDA UDI | Class I | Active |
| Calcigel | Regular Pack | FDA UDI | Class II | Active |
| Spectra Fresh Fruit | Intro Pack 75g jar | FDA UDI | Class I | Active |
| Zical Ultra | 15g powder | FDA UDI | Class II | Active |
| Micron Superior Capsules | Box of 10 | FDA UDI | Class II | Active |
| Hiflex Modelling Wax | 12 sheets 225g | FDA UDI | Class I | Active |
| Fusion I Seal | Regular Pack | FDA UDI | Class II | Active |
| Accusil Heavy Body | Regular Set 1 x 50ml | FDA UDI | Class II | Active |
| Prevest Model 3D Printing Resin | 1000g plastic bottle | FDA UDI | Class I | Active |
| Calplus | Economy Pack | EUDAMEDFDA UDI | Class II | Active |
| Spectra Fresh Orange | Intro Pack 75g jar | FDA UDI | Class I | Active |
| Accusil Monophase | Regular Set 1 x 50ml | FDA UDI | Class II | Active |
| Prevest Burn Out 3D Printing Resin | 1000g plastic bottle | FDA UDI | Class I | Active |
| Fusion I Seal | Economy Pack | FDA UDI | Class II | Active |
| Prevest C&B Permanent | 500g 18007 | FDA UDI | Class II | Active |
| Accusil Bite Registration | Regular Set / Fast Set 2 x 50ml | FDA UDI | Class II | Active |
| Magma NT | Intro Pack | FDA UDI | Class II | Active |
| Accusil Monophase | Regular Set 2 x 50ml | FDA UDI | Class II | Active |
| Hiflex Base Plates | 1.3mm 10 upper and 10 lower | FDA UDI | Class I | Active |
| Accusil Heavy Body | Regular Set 1 x 50ml | FDA UDI | Class II | Active |
| Zinconol | 75g powder | FDA UDI | Class I | Active |
| Accusil Heavy Body | Regular Set 2 x 50ml | FDA UDI | Class II | Active |
| Prevest Burn Out 3D Printing Resin | 500g plastic bottle | FDA UDI | Class I | Active |
| Zical Ultra Automix Paste | 15g | EUDAMEDFDA UDI | Class II | Active |
| Fusion I Seal | Large Pack | FDA UDI | Class II | Active |
| Fusion I Seal | Trial Pack | FDA UDI | Class II | Active |
| Spectra Fresh Strawberry | Intro Pack 75g jar | FDA UDI | Class I | Active |
| Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | K231696 | EUDAMEDFDA 510(k) | Class II | Active |
| CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | K212563 | EUDAMEDFDA 510(k) | Class II | Active |
| C&B Ceramic; C&B Permanent; C&B Interim | K233273 | FDA 510(k) | Class II | Active |
| Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) | K200555 | FDA 510(k) | Class II | Active |
| Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT | K231263 | FDA 510(k) | Class II | Active |
| Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | K212475 | EUDAMEDFDA 510(k) | Class II | Active |
| 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) | K213244 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Prevest Denpro Limited Jammu Jammu and Kashmir · IN FEI 3005628474