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Sign in to claim this brandPRIMA DENTAL MANUFACTURING LIMITED
US
Last updated May 24, 2026
What PRIMA DENTAL MANUFACTURING LIMITED makes
The company manufactures carbide and diamond rotary dental burs, including both reusable and single-use variants, designed for dental cutting and shaping procedures. These tools are used in procedures such as tooth preparation, cavity removal, and restorative dentistry, providing precision for dental professionals.
The portfolio is classified under FDA’s Class I medical devices and is listed in the FDA’s Unique Device Identification (UDI) system. The company operates from the United States, adhering to regulatory requirements for dental cutting instruments.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does PRIMA DENTAL MANUFACTURING LIMITED produce?
PRIMA DENTAL MANUFACTURING LIMITED produces carbide and diamond rotary dental burs, including both reusable and single-use variants. These dental tools are designed for cutting and shaping procedures in dentistry, such as tooth preparation and cavity removal.
Where is PRIMA DENTAL MANUFACTURING LIMITED based?
PRIMA DENTAL MANUFACTURING LIMITED is based in the United States. The company operates from this location while adhering to regulatory requirements for dental cutting instruments.
Which regulatory registries list PRIMA DENTAL MANUFACTURING LIMITED's devices?
The company's devices are listed in the FDA's Unique Device Identification (UDI) system. This registry tracks medical devices through unique identifiers to ensure proper tracking and safety monitoring.
How are PRIMA DENTAL MANUFACTURING LIMITED's devices classified?
The company's dental burs are classified under FDA's Class I medical devices. Class I devices are considered low-risk and subject to general controls, which include adherence to labeling, packaging, and performance standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- primadental.com
- —
- —
- [email protected]
- Phone
- +441452729751
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 216961108
Catalogue (387)
Page 3 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Carbide rotary dental burs | CDFXCT010RL170c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CROUND023HP375c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CFNBULG12FZ725c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CUREGG023FGH0CP | FDA UDI | Class I | Active |
| Carbide rotary dental burs | TPRSXCM12FGH0CP | FDA UDI | Class I | Active |
| Diamond roatry dental burs | DFZ5620M705e | FDA UDI | Class I | Active |
| Diamond roatry dental burs | DFM2033M615c | FDA UDI | Class I | Active |
| Diamond roatry dental burs | DFM5531M615c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | TTP08G010FD725c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CFFP31G10FL725c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CDET01016FG775c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CULTAP016FZH0CP | FDA UDI | Class I | Active |
| Carbide rotary dental burs | TEDFXC012FG725i | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CEGG01023FGH0CP | FDA UDI | Class I | Active |
| Carbide rotary dental burs | TP3DFX012FG120e | FDA UDI | Class I | Active |
| Carbide rotary dental burs | C7406XC18FG725c | FDA UDI | Class I | Active |
| Diamond roatry dental burs | DFM5633C615c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CRNDEX023RA775c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CULDET016FD725e | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CRNDEX018RA775c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CROUNDM23FXH0CP | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CROUNDM23RAH0CP | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CROUNDM21RAH0CP | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CROUND027RAH0CP | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CROUNDM23FGH0CP | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CROUND010FG170c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CINVCO008HP375c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CRNDEX025RA775c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CULTAP016FZ725e | FDA UDI | Class I | Active |
| Diamond roatry dental burs | DFM5571E615c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CFLA01G10FD725c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CROUND012RAH0CP | FDA UDI | Class I | Active |
| Carbide rotary dental burs | TPRAM0109FG120e | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CDET01G15FE725c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CDTFXL021HTS6Ps | FDA UDI | Class I | Active |
| Diamond roatry dental burs | DFM5966M615c | FDA UDI | Class I | Active |
| Diamond roatry dental burs | DFM2280C615c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CDET02G16FDH0CP | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CDET02M15FVH0CP | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CDET01G16FGH0CP | FDA UDI | Class I | Active |
| Carbide rotary dental burs | 100994 | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CFNEGGG18FG725c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CDET03016FD775c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CROUND018RL170c | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CROUNDM18FXH0CP | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CFFXCT010RAH0CP | FDA UDI | Class I | Active |
| Diamond roatry dental burs | DFGB368023C725e | FDA UDI | Class I | Active |
| Carbide rotary dental burs | TPRFFXC10FG120e | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CROUND008RAH0CP | FDA UDI | Class I | Active |
| Carbide rotary dental burs | CEF402G10FZ725c | FDA UDI | Class I | Active |
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