FDA.reportPublic FDA data

A-dec

Primary DI
10194665005528
Brand
A-dec
Company
A-DEC, INC.
Model
54.0879.001
Catalog number
54.0879.00
Device description
Air LS Package,A11,Class A,OTC
Published
2022-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EFAHandpiece, Belt And/Or Gear Driven, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFAHandpiece, Belt And/Or Gear Driven, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143465000MASTERmatic LUXKaltenbach & Voigt GmbH2015-04-09EFA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10194665005528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019466500552810194665005528

GMDN Terms#

Term, Definition table
TermDefinition
Remotely-driven surgical/dental system drive cableA flexible device for transmitting rotational power from a remote surgical or dental drilling system motor/control unit to the drilling handpiece. The drive is designed so that the handpiece can be flexibly manipulated by the operator (the surgeon or dentist). The design is typically based on a rotating metal spun spiral cable within a protective sheath; this is commonly known as a Bowden cable. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009617473
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10194665008857A-decS76S762026-05-07
10194665008444A-dec54.0924.0154.0924.012026-02-19
10194665008475A-dec54.1073.0054.1073.002026-02-19
10194665008482A-dec54.1073.0154.1073.012026-02-19
10194665008499A-dec54.1074.0054.1074.002026-02-19
10194665008505A-dec54.1074.0154.1074.012026-02-19
10194665008512A-dec54.1051.0054.1051.002026-02-19
10194665008529A-dec54.1052.0054.1052.002026-02-19
10194665008550A-dec54.1076.0054.1076.002026-02-19
10194665004460A-dec54.0865.0054.0865.002022-11-07
10194665008697A-dec3453452026-02-17
10194665008666A-decAMDUWLAMDUWL2025-09-30
10194665008383A-dec311xlc311xlc2025-09-18
10194665006587A-dec311FLT311FLT2025-05-19
10194665006594A-dec511FLT511FLT2025-05-19
10194665007935ActeonC202025-05-15
10194665008321A-decNo Version or Model Number54.1042.002025-05-15
10194665008345A-decNo Version or Model Number54.1043.002025-05-15
10194665007928A-dec 54.1041.0054.1041.002025-02-11
10194665007911A-dec346134612025-01-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
03663394169936AXIOM®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
04548213008476N/AJ.MORITA MFG.CORP.EFA2022-12-12
04548213008483N/AJ.MORITA MFG.CORP.EFA2022-12-12
04548213008506N/AJ.MORITA MFG.CORP.EFA2022-12-12
04548213008513TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008537TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008544TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008551TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008568TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008575TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008582TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008599TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12