FDA.reportPublic FDA data

Carbide rotary dental burs

Primary DI
85056020710086
Brand
Carbide rotary dental burs
Company
PRIMA DENTAL MANUFACTURING LIMITED
Model
CROUND023RLH0CP
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
05056020710080PrimaryGS10
85056020710086Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056020710080050560207100805056020710080
8505602071008685056020710086

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
216961108
Device count
100
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
85056020700049Carbide rotary dental bursCRNDEX010RA775c2023-02-08
85056020700063Carbide rotary dental bursCRNDEX012RA775c2023-02-08
85056020700070Carbide rotary dental bursCRNDEX014RA775c2023-02-08
85056020700094Carbide rotary dental bursCRNDEX016RA775c2023-02-08
85056020700100Carbide rotary dental bursCRNDEX018RA775c2023-02-08
85056020700124Carbide rotary dental bursCRNDEX021RA775c2023-02-08
85056020700131Carbide rotary dental bursCRNDEX023RA775c2023-02-08
85056020700155Carbide rotary dental bursCRNDEX025RA775c2023-02-08
85056020700162Carbide rotary dental bursCRNDEX027RA775c2023-02-08
85056020700827Carbide rotary dental bursCTFXCL009FZ775c2023-02-08
85056020701701Carbide rotary dental bursCFFXCT010FG170c2023-02-08
85056020701923Carbide rotary dental bursCINVCO016FG170c2023-02-08
85056020702043Carbide rotary dental bursCPEARN012FG170c2023-02-08
85056020702135Carbide rotary dental bursCROUND008FG170c2023-02-08
85056020702166Carbide rotary dental bursCROUND010FG170c2023-02-08
85056020702296Carbide rotary dental bursCTFPCL010FZ170c2023-02-08
85056020702784Carbide rotary dental bursCDFXCT012FGS1Bs2023-02-08
85056020702807Carbide rotary dental bursCFFXCT010FGS1Bs2023-02-08
85056020702944Carbide rotary dental bursTPEARN008FGS1Bs2023-02-08
85056020703231Carbide rotary dental bursCDFXCT012FZH0CP2023-02-08

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