FDA.reportPublic FDA data

MEDIDENTA

Primary DI
00810988031848
Brand
MEDIDENTA
Company
HANDPIECE PARTS & REPAIRS, INC.
Model
EJ0008-MEDI-MT
Catalog number
EJ0008-MEDI-MT
Device description
Medidenta Medilectric 40K Brushless/ LED/ Motor Only
Published
2023-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00810988031848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810988031848008109880318488109880318480810988031848

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motor, electricA hand-held, electrically-powered component of a dental power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy for drilling or sawing during dental surgery. It is designed to accept handpiece components/attachments (not included) and is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It might be operated with a hand- or foot-switch. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079723355
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810988030292TTBio08090012TB508090012TB52025-06-04
00810988030308TTBio08090012TB408090012TB42025-06-04
00810988030827QUALITY PLUSPB01PPB01P2023-07-17
10810988031302EDGE ENDOEEALULH5EEALULH52023-04-20
10810988031326EDGE ENDOEEALUFC5EEALUFC52023-04-20
00810988031312EDGE ENDOEEALUMFEEALUMF2023-04-20
00810988031336EDGE ENDOEEALUMWEEALUMW2023-04-20
00810988031350EDGE ENDOEEALUTEEALUT2023-04-20
00810988031374EDGE ENDOEEDPUEEDPU2023-04-20
00810988031404EDGE ENDOEEDPUT3504EEDPUT35042023-04-20
00810988031411EDGE ENDOEEDPUT4004EEDPUT40042023-04-20
00810988031428EDGE ENDOEEDPUT4504EEDPUT45042023-04-20
00810988031435EDGE ENDOEEDPUT5004EEDPUT50042023-04-20
00810988031442EDGE ENDOEEDPUT5506EEDPUT55062023-04-20
00810988031459EDGE ENDOEEDPUT5508EEDPUT55082023-04-20
00810988031466EDGE ENDOEEDPUT5510EEDPUT55102023-04-20
00810988031473EDGE ENDOEEDPUT5508LEEDPUT5508L2023-04-20
00810988031480EDGE ENDOEEDPUT6012EEDPUT60122023-04-20
00810988031497EDGE ENDOEEPTOEEPTO2023-04-20
00810988031541EDGE ENDOEE20GSINEE20GSIN2023-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589551395088Multi Pad2NAKANISHI INC.EBW2026-06-02
08033837935889AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935896AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935902Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935919Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935926CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935933CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08809260475519X-CUBESaeshin Precision Co., Ltd.EBW2026-04-02
08809260475403AHP-85-SSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475410TRAUSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475359SDI10Saeshin Precision Co., Ltd.EBW2026-03-04
10194665008444A-decA-DEC, INC.EBW2026-02-19
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
E27668302980Midwest Power Lux Implant MotorSIRONA Dental Systems GmbHEBW2026-02-13
E27668303060Midwest Power Lux MotorSIRONA Dental Systems GmbHEBW2026-02-13
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
04589551393381Straumann SGL80MNAKANISHI INC.EBW2026-01-03
04589551393374Straumann Surgical Motor Pro 2NAKANISHI INC.EBW2026-01-03
04589551384082Straumann SGL80MNAKANISHI INC.EBW2026-01-03
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHEBW2025-12-18