FDA.reportPublic FDA data

Carbide rotary dental burs

Primary DI
85056020706140
Brand
Carbide rotary dental burs
Company
PRIMA DENTAL MANUFACTURING LIMITED
Model
CFFXCT016HP375c
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
05056020706144PrimaryGS10
85056020706140Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056020706144050560207061445056020706144
8505602070614085056020706140

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
5
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
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
05056020702788Carbide rotary dental bursCDFXCT012FGS1Bs2023-02-08
05056020702801Carbide rotary dental bursCFFXCT010FGS1Bs2023-02-08
05056020702948Carbide rotary dental bursTPEARN008FGS1Bs2023-02-08
05056020703235Carbide rotary dental bursCDFXCT012FZH0CP2023-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ESUNC1623160165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2025-04-29
07630049901384C141 Allport bone cutterDiaswiss SAEJL2023-10-02
07630049901612DIA-ZDiaswiss SAEJL2023-10-02
07630049902077Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951051Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951075Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951532Carbide bur Diacarb FG HCDiaswiss SAEJL2023-10-02
07630049951556FG Diacarb finishing bur HCDiaswiss SAEJL2023-10-02
07630049951921C141 Allport bone cutterDiaswiss SAEJL2023-10-02
07630049951983Carbide bur Diacarb RA HCDiaswiss SAEJL2023-10-02
07630049952003Carbide finishing bur Diacarb RADiaswiss SAEJL2023-10-02
07630049952041FG Diacarb carbide crown cutterDiaswiss SAEJL2023-10-02
07630049952065Carbide bur Diacarb FG HCDiaswiss SAEJL2023-10-02
07630049952089FG Diacarb finishing burDiaswiss SAEJL2023-10-02
07630049952164FG Diacarb finishing burDiaswiss SAEJL2023-10-02
07630049952188FG Diacarb finishing burDiaswiss SAEJL2023-10-02
ESUNC283K3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-25
ESUNC33L3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC33L3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040185Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040275Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCTR323140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC463140145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07