FDA.reportPublic FDA data

MK-dent

Primary DI
E490AM00021
Brand
MK-dent
Company
MK-Dent GmbH
Model
ACCESSORIES
Catalog number
AM0002
Device description
Air Motor
Published
2024-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
EFBHandpiece, Air-Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051872000MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011Mk-Dent GmbH2005-10-03EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050546000015PreviousGS10
E490AM00021PrimaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050546000015040505460000154050546000015

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motor, pneumaticA hand-held, pneumatically-powered component of a surgical power tool assembly designed to convert the energy from a compressed gas source [e.g., surgical-grade air or nitrogen (N2)] 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

Regulatory Flags#

DUNS number
343618943
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E490LCH211MK-dentCLASSIC LINELCH212024-10-14
E490AM00041MK-dentACCESSORIESAM00042024-10-14
E490AM00121MK-dentACCESSORIESAM00122024-10-14
E490AM00141MK-dentACCESSORIESAM00142024-10-14
E490AM10021MK-dentACCESSORIESAM10022024-10-14
E490AM10041MK-dentACCESSORIESAM10042024-10-14
E490AM10061MK-dentACCESSORIESAM10062024-10-14
E490AM11161MK-dentACCESSORIESAM11162024-10-14
E490HB121MK-dentBASIC LINEHB122024-10-14
E490HB141MK-dentBASIC LINEHB142024-10-14
E490HB15L1MK-dentBASIC LINEHB15L2024-10-14
E490HB16L1MK-dentBASIC LINEHB16L2024-10-14
E490HB21K1MK-dentBASIC LINEHB21K2024-10-14
E490HB21KL1MK-dentBASIC LINEHB21KL2024-10-14
E490HB23K1MK-dentBASIC LINEHB23K2024-10-14
E490HB23KL1MK-dentBASIC LINEHB23KL2024-10-14
E490HC20K1MK-dentCLASSIC LINEHC20K2024-10-14
E490HC20KL1MK-dentCLASSIC LINEHC20KL2024-10-14
E490HC21K1MK-dentCLASSIC LINEHC21K2024-10-14
E490HC21KL1MK-dentCLASSIC LINEHC21KL2024-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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D950133832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133842360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133952360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134802360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134812360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134822360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134842360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134952360Xtreme PowerLARES RESEARCHEFB2026-09-04
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