FDA.reportPublic FDA data

Carbide rotary dental burs

Primary DI
05056020702788
Brand
Carbide rotary dental burs
Company
PRIMA DENTAL MANUFACTURING LIMITED
Model
CDFXCT012FGS1Bs
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056020702788PrimaryGS10
85056020702784Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056020702788050560207027885056020702788
8505602070278485056020702784

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, single-useA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+441452729751sales@primadental.com

Regulatory Flags#

DUNS number
216961108
Device count
25
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056020700043Carbide rotary dental bursCRNDEX010RA775c2023-02-08
05056020700067Carbide rotary dental bursCRNDEX012RA775c2023-02-08
05056020700074Carbide rotary dental bursCRNDEX014RA775c2023-02-08
05056020700098Carbide rotary dental bursCRNDEX016RA775c2023-02-08
05056020700104Carbide rotary dental bursCRNDEX018RA775c2023-02-08
05056020700128Carbide rotary dental bursCRNDEX021RA775c2023-02-08
05056020700135Carbide rotary dental bursCRNDEX023RA775c2023-02-08
05056020700159Carbide rotary dental bursCRNDEX025RA775c2023-02-08
05056020700166Carbide rotary dental bursCRNDEX027RA775c2023-02-08
05056020700821Carbide rotary dental bursCTFXCL009FZ775c2023-02-08
05056020701705Carbide rotary dental bursCFFXCT010FG170c2023-02-08
05056020701927Carbide rotary dental bursCINVCO016FG170c2023-02-08
05056020702047Carbide rotary dental bursCPEARN012FG170c2023-02-08
05056020702139Carbide rotary dental bursCROUND008FG170c2023-02-08
05056020702160Carbide rotary dental bursCROUND010FG170c2023-02-08
05056020702290Carbide rotary dental bursCTFPCL010FZ170c2023-02-08
05056020702801Carbide rotary dental bursCFFXCT010FGS1Bs2023-02-08
05056020702948Carbide rotary dental bursTPEARN008FGS1Bs2023-02-08
05056020703235Carbide rotary dental bursCDFXCT012FZH0CP2023-02-08
05056020703433Carbide rotary dental bursCFFPCT008FGH0CP2023-02-08

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Primary DI, Brand, Company table
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