FDA.reportPublic FDA data

MK-dent

Primary DI
LCH211
Brand
MK-dent
Company
MK-Dent GmbH
Model
CLASSIC LINE
Catalog number
LCH21
Device description
Contra Angle Head
Published
2024-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
04050546002927PreviousGS10
LCH211PrimaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050546002927040505460029274050546002927

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool handpiece motorless componentA component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
343618943
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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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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