FDA.report

Henry Schein Maxima

Primary DI
00304040116111
Brand
Henry Schein Maxima
Company
HENRY SCHEIN, INC.
Model
5700685
Catalog number
5700685
Device description
Maxima Electric Micromotor
Published
2019-11-12
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
EBWController, foot, handpiece and cord

Product Code Classifications

CodeDeviceSpecialtyClass
EBWController, Foot, Handpiece And CordDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040116111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040116111003040401161113040401161110304040116111

GMDN Terms

TermDefinition
Dental power tool system handpiece, line-poweredA hand-held, mains electricity (AC-powered) dental device that includes a chuck or collet for attaching a dental endpiece (e.g., drill bit, bur, reamer, saw blade, polishing disk) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. It is powered by a low-voltage electric micro-motor (e.g., 24 volt) that is an integral part of the device; the endpiece(s) are not included. It is typically connected through the dental delivery system or a freestanding independent control unit. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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
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