FDA.reportPublic FDA data

MK-dent Germany®

Primary DI
04050546002750
Brand
MK-dent Germany®
Company
MK-Dent GmbH
Model
LB41
Published
2016-09-24
Public version status
Update
Distribution status
Not 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
04050546002750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050546002750040505460027504050546002750

GMDN Terms#

Term, Definition table
TermDefinition
Dental drilling system attachmentA device, e.g., a straight, contra-angle or right-angle attachment, that is connected to a drill handpiece to achieve a specific function such as accessing intraoral areas that are difficult to reach when cleaning teeth, or preparing dental cavities for restorations (e.g., fillings) or preparing teeth for crowns and bridges. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
343618943
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E490LCH211MK-dentCLASSIC LINELCH212024-10-14
E490AM00021MK-dentACCESSORIESAM00022024-10-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D7022666540StarDentalDENTALEZ, INC.EFB2026-09-18
D7022666550StarDentalDENTALEZ, INC.EFB2026-09-18
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D950133822360Xtreme PowerLARES RESEARCHEFB2026-09-04
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
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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
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