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PRIMA DENTAL MANUFACTURING LIMITED

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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +441452729751
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 216961108

Catalogue (387)

Page 8 of 8

Device	Model / Reference	Registries	Class	Status
Carbide rotary dental burs	CEGG01G23FGH0CP	FDA UDI	Class I	Active
Carbide rotary dental burs	CROUNDH23HLH0CP	FDA UDI	Class I	Active
Carbide rotary dental burs	CDET31G09FZ725c	FDA UDI	Class I	Active
Carbide rotary dental burs	102819	FDA UDI	Class I	Active
Carbide rotary dental burs	CIPX31G12FGH0CP	FDA UDI	Class I	Active
Carbide rotary dental burs	CDTFXC021HPS6Ps	FDA UDI	Class I	Active
Diamond roatry dental burs	DFM5626M615c	FDA UDI	Class I	Active
Carbide rotary dental burs	CSET32G14FJH0CP	FDA UDI	Class I	Active
Carbide rotary dental burs	100990	FDA UDI	Class I	Active
Carbide rotary dental burs	CFFXCT008HP375c	FDA UDI	Class I	Active
Carbide rotary dental burs	CFNNEE012FZH0CP	FDA UDI	Class I	Active
Carbide rotary dental burs	101017	FDA UDI	Class I	Active
Carbide rotary dental burs	CSET01G09FD725c	FDA UDI	Class I	Active
Carbide rotary dental burs	CTFXCT021HTH0CP	FDA UDI	Class I	Active
Diamond roatry dental burs	DFZ2170F705e	FDA UDI	Class I	Active
Diamond roatry dental burs	DFGB368023X725e	FDA UDI	Class I	Active
Carbide rotary dental burs	CFNFLAG23FG725c	FDA UDI	Class I	Active
Carbide rotary dental burs	TROUNDM14FGH0CP	FDA UDI	Class I	Active
Diamond roatry dental burs	DFM2571C615c	FDA UDI	Class I	Active
Carbide rotary dental burs	100999	FDA UDI	Class I	Active
Carbide rotary dental burs	CULDET010FD725e	FDA UDI	Class I	Active
Diamond roatry dental burs	DFM5931E615c	FDA UDI	Class I	Active
Carbide rotary dental burs	100981	FDA UDI	Class I	Active
Carbide rotary dental burs	CTFXCT021HTS6Ps	FDA UDI	Class I	Active
Carbide rotary dental burs	CFNRNDG10FG725c	FDA UDI	Class I	Active
Carbide rotary dental burs	CROUND021HP375c	FDA UDI	Class I	Active
Carbide rotary dental burs	CFNTAPG14FJ725c	FDA UDI	Class I	Active
Carbide rotary dental burs	CTFXCT021HPS6Ps	FDA UDI	Class I	Active
Diamond roatry dental burs	DFM5620M615c	FDA UDI	Class I	Active
Carbide rotary dental burs	TTP12G014FE725c	FDA UDI	Class I	Active
Carbide rotary dental burs	C274XC016FG725c	FDA UDI	Class I	Active
Carbide rotary dental burs	CSET03016RA775c	FDA UDI	Class I	Active
Carbide rotary dental burs	CFNTAPG12FG725c	FDA UDI	Class I	Active
Diamond roatry dental burs	DFGB850016C725e	FDA UDI	Class I	Active
Carbide rotary dental burs	CPEARN008FGH0CP	FDA UDI	Class I	Active
Carbide rotary dental burs	CFNRNDG18FG725c	FDA UDI	Class I	Active
Carbide rotary dental burs	CRNDLNM14RLH0CP	FDA UDI	Class I	Active

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