FDA.reportPublic FDA data

IM1 HANDPIECE

Primary DI
04719873120345
Brand
IM1 HANDPIECE
Company
BONART CO., LTD.
Model
73120345
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100785000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100785000BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIESBonart Co., Ltd.2010-12-03EBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719873120345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873120345047198731203454719873120345

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657263687
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873121854ARTART-P3II PRO2026-04-27
04719873121861ARTART-M3II PRO2026-04-27
04719873121281GT1 Blade Type ElectrodeGT12020-02-27
04719873121298GT2 Small Loop ElectrodeGT22020-02-27
04719873121304GT3 Large Loop ElectrodeGT32020-02-27
04719873121311GT4 Fine Wire ElectrodeGT42020-02-27
04719873121328GT5 Heavy Wire ElectrodeGT52020-02-27
04719873121335GT8 Heavy Ball Electrode (2.38mm)GT82020-02-27
04719873121342GT9 Heavy Ball Electrode (5mm)GT92020-02-27
04719873120048ELECTROSURGERY SYSTEMART-E1 2016-09-20
04719873120161E1 Hand Piece731201612016-09-20
04719873120178E1 Indifference plate EU0004-002R 2016-09-20
04719873120185E1 electrode set (7 tips)731201852016-09-20
04719873120468T1 Diamond shaped electrodeT12016-09-20
04719873120475T2 Small loop electrodeT22016-09-20
04719873120482T3 Large loop electrodeT32016-09-20
04719873120499T4 Fine wire electrodeT4 2016-09-20
04719873120505T5 Heavy wire electrodeT52016-09-20
04719873120512T7 Fine oval loop electrodeT72016-09-20
04719873120529T9 Heavy ball electrodeT9 2016-09-20

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