FDA.reportPublic FDA data

Contra Angle

Primary DI
D716TUL8M1
Brand
Contra Angle
Company
TULSA DENTAL PRODUCTS LLC
Model
TUL-8M
Catalog number
TUL-8M
Device description
W&H Contra Angle 8:1 Ratio (30091002)
Published
2023-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EFBHandpiece, air-powered, dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D716TUL8M1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental laboratory drilling system handpieceA hand-held device that includes a chuck for attaching drills, burs, grind wheels, and similar rotating devices used in the dental laboratory. The device is typically remote from the power source (e.g., a dental laboratory drill motor) and is connected to this by a flexible drive system, which may be a Bowden cable. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
942778564
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D716GTPOSTFSAM1GT Post and DrillsGTPOSTFSAMGTPOSTFSAM2022-09-01
D716BP156L1BioPureBPSYRNDL2BP156L2022-10-13
D716BP156P1BioPureBPSYRNDL2BP156P2022-10-13
D716BP156SYS1BioPureBPSYRNDL2BP156SYS2022-10-13
D716BP288P1BioPureBPSYRNDL2BP288P2022-10-13
D716BP36L1BioPureBPSYRNDL2BP36L2022-10-13
D716BP36P1BioPureBPSYRNDL2BP36P2022-10-13
D716BP36SYS1BioPureBPSYRNDL2BP36SYS2022-10-13
D716BP48L1BioPureBPSYRNDL2BP48L2022-10-13
D716BP48P1BioPureBPSYRNDL2BP48P2022-10-13
D716BP48R1BioPureBPSYRNDL2BP48R2022-10-13
D716BPSYRNDL21BioPureBPSYRNDL2BPSYRNDL22022-10-13
D716PIEZOFLOWREFILL1ProUltra PiezoFlowPIEZOFLOWREFILLPIEZOFLOWREFILL2022-10-18
D716PUENDO11ProUltraPUENDO1PUENDO12016-10-07
D716PUENDO151ProUltraPUENDO1-5PUENDO1-52016-11-11
D716PUENDO21ProUltraPUENDO2PUENDO22016-10-07
D716PUENDO31ProUltraPUENDO3PUENDO32016-10-07
D716PUENDO41ProUltraPUENDO4PUENDO42016-10-07
D716PUENDO51ProUltraPUENDO5PUENDO52016-10-07
D716PUENDO61ProUltraPUENDO6PUENDO62016-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D7022666540StarDentalDENTALEZ, INC.EFB2026-09-18
D7022666550StarDentalDENTALEZ, INC.EFB2026-09-18
D950133802360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133812360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133822360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133842360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133952360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134802360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134812360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134822360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134842360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134952360Xtreme PowerLARES RESEARCHEFB2026-09-04
J0071602490011HOSE MX2 400 GREY_102646BIEN-AIR PORTUGAL, UNIPESSOAL, LDAEFB2026-08-27
07613353240011AIR-FLOWE.M.S. Electro Medical Systems S.A.EFB2026-07-21
07613353046897AIR-FLOW® PERIO handy 3.0 PERIO handpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14
07613353239992AIR-FLOW Handpiece 120°E.M.S. Electro Medical Systems S.A.EFB2026-07-14