FDA.report

A-dec

Primary DI
10194665000608
Brand
A-dec
Company
A-DEC, INC.
Model
54.0446.00
Catalog number
54.0446.00
Device description
Electric Motor Kit,Nano,Control Module,61 IN,OTC
Published
2022-11-02
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

Related Records

Product Codes

CodeName
EBWController, Foot, Handpiece And Cord

Product Code Classifications

CodeDeviceSpecialtyClass
EBWController, Foot, Handpiece And CordDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10194665000608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1019466500060810194665000608

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
009617473
Device count
1
DM exempt
false
Premarket exempt
false
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

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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
10194665007164A-dec54.1003.0054.1003.002024-11-05
10194665007171A-dec54.1004.0054.1004.002024-11-05
10194665007188A-dec54.1005.0054.1005.002024-11-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08809260475359SDI10Saeshin Precision Co., Ltd.EBW2026-03-04
10194665008475A-decA-DEC, INC.EBW2026-02-19
10194665008482A-decA-DEC, INC.EBW2026-02-19
10194665008499A-decA-DEC, INC.EBW2026-02-19
10194665008505A-decA-DEC, INC.EBW2026-02-19
10194665008512A-decA-DEC, INC.EBW2026-02-19
10194665008529A-decA-DEC, INC.EBW2026-02-19
10194665008550A-decA-DEC, INC.EBW2026-02-19
E27668312130Midwest Motor Control ModuleSIRONA Dental Systems GmbHEBW2026-02-17
00810126043153SM7 US ( Complete Set )HIOSSEN, INC.EBW2026-01-09
00810126043160S200EML (Contra) Dental Surgery Hand PieceHIOSSEN, INC.EBW2026-01-09
08404535021684ForzaPeter Brasseler Holdings, LLCEBW2026-01-09
08404535021714ForzaPeter Brasseler Holdings, LLCEBW2026-01-09
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04589551384082Straumann SGL80MNAKANISHI INC.EBW2026-01-03
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04589551381500NLZNAKANISHI INC.EBW2025-08-26
04589551381517NLZNAKANISHI INC.EBW2025-08-26
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04589551392889Surgic Pro2 NON-OPTNAKANISHI INC.EBW2025-08-26
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04560264575165Nozzle HolderNAKANISHI INC.EBW2024-11-15
04560264575172Internal Spray NozzleNAKANISHI INC.EBW2024-11-15