FDA.reportPublic FDA data

ELEC Master

Primary DI
08800156000013
Brand
ELEC Master
Company
MGNEWTON Co. LTD.,
Model
ELEC Master Dual
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202963000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202963000ELEC Master, ELEC Master DualMgnewton , Ltd.2023-05-05EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800156000013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800156000013088001560000138800156000013

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motorized handpiece/set, electricAn electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
0532146287shpark@mgnewton.com

Regulatory Flags#

DUNS number
688336182
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898971838004OlsenOlsen Indústria e Comércio S/AEIA2026-04-22
J00715021220011BOARD DMX3 M BornierBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
50732224005671DentaPure Water Purification Bottle CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
50732224005688DentaPure Water Purification Municipal CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11
10817417020098AsepticoASEPTICO, INC.EIA2022-12-08
10817417020135AsepticoASEPTICO, INC.EIA2022-12-08
10817417021309AsepticoASEPTICO, INC.EIA2022-12-08
10817417021507AsepticoASEPTICO, INC.EIA2022-12-08
10817417021514AsepticoASEPTICO, INC.EIA2022-12-08
10817417021521AsepticoASEPTICO, INC.EIA2022-12-08
10817417021538AsepticoASEPTICO, INC.EIA2022-12-08
10817417021545AsepticoASEPTICO, INC.EIA2022-12-08
10817417021552AsepticoASEPTICO, INC.EIA2022-12-08
10817417021569AsepticoASEPTICO, INC.EIA2022-12-08
10817417021576AsepticoASEPTICO, INC.EIA2022-12-08
10817417021583AsepticoASEPTICO, INC.EIA2022-12-08
10817417021590AsepticoASEPTICO, INC.EIA2022-12-08
10817417021606AsepticoASEPTICO, INC.EIA2022-12-08
10817417021613AsepticoASEPTICO, INC.EIA2022-12-08
10817417021835AsepticoASEPTICO, INC.EIA2022-12-08
10817417021842AsepticoASEPTICO, INC.EIA2022-12-08
10817417021859AsepticoASEPTICO, INC.EIA2022-12-08