FDA.reportPublic FDA data

A-dec

Primary DI
10194665003012
Brand
A-dec
Company
A-DEC, INC.
Model
54.0602.00
Catalog number
54.0602.00
Device description
A-dec NLZ,Motor,Electric
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

Product Codes#

Code, Name table
CodeName
EBWController, Foot, Handpiece And Cord

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBWController, Foot, Handpiece And CordDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10194665003012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019466500301210194665003012

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10194665008697A-dec3453452026-02-17
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
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 DI, Brand, Company table
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
04589551393374Straumann Surgical Motor Pro 2NAKANISHI INC.EBW2026-01-03
04589551384082Straumann SGL80MNAKANISHI INC.EBW2026-01-03
J021081659500Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHEBW2025-12-18
04589551381500NLZNAKANISHI INC.EBW2025-08-26
04589551381517NLZNAKANISHI INC.EBW2025-08-26
04589551381531NLZNAKANISHI INC.EBW2025-08-26
04589551381562NLZNAKANISHI INC.EBW2025-08-26
04589551381586NLZNAKANISHI INC.EBW2025-08-26
04589551381609Multi Pad2NAKANISHI INC.EBW2025-08-26
04589551381647NLZNAKANISHI INC.EBW2025-08-26
04589551392872Surgic Pro2 OPTNAKANISHI INC.EBW2025-08-26
04589551392889Surgic Pro2 NON-OPTNAKANISHI INC.EBW2025-08-26
J00716011920011WIRELESS FOOTCTRL + DONGLEBien-Air Dental SAEBW2025-02-20
J00717008890011Set Console CHIROPRO L US PREMIUM WLBien-Air Dental SAEBW2025-02-20
04560264575158Nozzle HolderNAKANISHI INC.EBW2024-11-15
04560264575165Nozzle HolderNAKANISHI INC.EBW2024-11-15
04560264575172Internal Spray NozzleNAKANISHI INC.EBW2024-11-15