FDA.report

AXIOM®

Primary DI
03663394169936
Brand
AXIOM®
Company
ETABLISSEMENTS ANTHOGYR
Model
10401XL
Device description
IMPL. CA WITH LIGHT+DEPTH STOP
Published
2023-12-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EFAHandpiece, belt and/or gear driven, dental

Product Code Classifications

CodeDeviceSpecialtyClass
EFAHandpiece, Belt And/Or Gear Driven, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03663394169936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03663394169936036633941699363663394169936

GMDN Terms

TermDefinition
Dental power tool handpiece motorless componentA component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
275978864
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
03663394482325HAND-PIECES / CONTRE-ANGLES47562025-12-17
03663394865371HAND-PIECES / CONTRE-ANGLES1600911-0012025-08-20
03663394170871IMPULSION87M2025-02-13
03663394482332Anthogyr OSTEOTOMEINMODOSTSV2024-07-17
03663394011099TORQCONTROL155012024-03-28
03663394173346Anthogyr UNIVERSAL SURGICAL INSTRUMENTINUSI2024-02-27
03663394482936AXIOM®INBW100XL2024-01-23
03663394484275AXIOM®OPFPSL20-ET2024-01-19
03663394484282AXIOM®OPGS20-ET2024-01-19
03663394484299AXIOM®OPGS36-ET2024-01-19
03663394484305AXIOM®OPGS42-ET2024-01-19
03663394484312AXIOM®OPGS50-ET2024-01-19
03663394484329AXIOM®OPFP20-ET2024-01-19
03663394165532AXIOM®OPFPSL20-52024-01-17
03663394165549AXIOM®OPFP202024-01-17
03663394479288AXIOM®INSETIGM2024-01-17
03663394479295AXIOM®OPFPD202024-01-17
03663394479301AXIOM®OPFPSL20-32024-01-17
03663394479318AXIOM®OPGS202024-01-17
03663394479325AXIOM®OPGS20-42024-01-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04548213060153STERLINGJ.MORITA MFG.CORP.EFA2026-02-20
04548213060160STERLINGJ.MORITA MFG.CORP.EFA2026-02-20
04548213060177STERLINGJ.MORITA MFG.CORP.EFA2026-02-20
04548213057320TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
04548213057337TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
04548213057344TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
04548213057368TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
04548213057375TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
03663394482325HAND-PIECES / CONTRE-ANGLESETABLISSEMENTS ANTHOGYREFA2025-12-17
03663394865371HAND-PIECES / CONTRE-ANGLESETABLISSEMENTS ANTHOGYREFA2025-08-20
D950116461PastelLARES RESEARCHEFA2025-05-02
03663394170871IMPULSIONETABLISSEMENTS ANTHOGYREFA2025-02-13
00304040189641MaximaHENRY SCHEIN, INC.EFA2025-01-14
EKAV101402800MASTERmatic LUX M45 LKaVo Dental GmbHEFA2024-02-01
03663394170796AXIOM®ETABLISSEMENTS ANTHOGYREFA2023-12-28
03663394169929AXIOM®ETABLISSEMENTS ANTHOGYREFA2023-12-27
04548213745043Midwest 45 FBE NFOJ.MORITA MFG.CORP.EFA2023-08-18
04548213745241Midwest 45 K-Style NFOJ.MORITA MFG.CORP.EFA2023-08-18
10194665005528A-decA-DEC, INC.EFA2022-11-21
10194665004521A-decA-DEC, INC.EFA2022-11-07
10194665004538A-decA-DEC, INC.EFA2022-11-07
D7166640010SureFlex NiTi Rotary FileTULSA DENTAL PRODUCTS LLCEFA2022-10-27
D7166640020SureFlex NiTi Rotary FileTULSA DENTAL PRODUCTS LLCEFA2022-10-27
D7166640030SureFlex NiTi Rotary FileTULSA DENTAL PRODUCTS LLCEFA2022-10-27
D7166640040SureFlex NiTi Rotary FileTULSA DENTAL PRODUCTS LLCEFA2022-10-27
D7166640050SureFlex NiTi Rotary FileTULSA DENTAL PRODUCTS LLCEFA2022-10-27
D7166640060SureFlex NiTi Rotary FileTULSA DENTAL PRODUCTS LLCEFA2022-10-27
D7166640070SureFlex NiTi Rotary FileTULSA DENTAL PRODUCTS LLCEFA2022-10-27
D7166640080SureFlex NiTi Rotary FileTULSA DENTAL PRODUCTS LLCEFA2022-10-27
D7166640090SureFlex NiTi Rotary FileTULSA DENTAL PRODUCTS LLCEFA2022-10-27