FDA.reportPublic FDA data

MK-dent Germany®

Primary DI
04050546003030
Brand
MK-dent Germany®
Company
MK-Dent GmbH
Model
LE27
Published
2016-09-24
Public version status
Update
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
04050546003030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050546003030040505460030304050546003030

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
07613353240011AIR-FLOWE.M.S. Electro Medical Systems S.A.EFB2026-07-21
07613353046897AIR-FLOW® PERIO handy 3.0 PERIO handpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14
07613353239992AIR-FLOW Handpiece 120°E.M.S. Electro Medical Systems S.A.EFB2026-07-14
07613353240134PERIO-FLOW HandpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14
07613353312558AIR-FLOW® PLUS handy 3.0 PERIO handpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14
07613353344238PERIO-FLOW HandpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14
00840456222843JMUJMU DENTAL, INCEFB2026-06-25
00840456222850JMUJMU DENTAL, INCEFB2026-06-25
00810021439778DCI EdgeDCI International, LLCEFB2026-06-01
00810021439785DCI EdgeDCI International, LLCEFB2026-06-01
07640397422028Statcare sprayDent4You AGEFB2026-04-24
07640397422035Statmatic sprayDent4You AGEFB2026-04-24
J021020835001MCA-RM-BCW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J0071600436001USA1PM 1:2Bien-Air Dental SAEFB2025-10-13
J0071600052001USA1PM 1:1 EXT SPRAYBien-Air Dental SAEFB2025-10-10
J0071600692001USA1CA 20:1 L MICRO-SERIESBien-Air Dental SAEFB2025-10-10
J0071601136001USA1CA NOVA 1:1L MSBien-Air Dental SAEFB2025-10-10
J0071601138001USA1CA NOVA 1:5L MSBien-Air Dental SAEFB2025-10-10
07613353342067AIR-FLOWE.M.S. Electro Medical Systems S.A.EFB2025-07-07
07613353342074AIR-FLOWE.M.S. Electro Medical Systems S.A.EFB2025-07-07
J021300850001WG-67 AW & H Dentalwerk Bürmoos GmbHEFB2025-03-04
J021300740001TE-95 BC TurbineW & H Dentalwerk Bürmoos GmbHEFB2024-07-29
J021112330111OS30W & H Dentalwerk Bürmoos GmbHEFB2024-07-03
J00715031850011NGO motor driverBien-Air Dental SAEFB2023-09-15
J021026904001MCA-RM-RQW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021026930001MCA-ISO-CKW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021031035001MCA-ISO-MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021052046001MCA-ISO-PLW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021060371001Universal Adapter VDWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021111443001RC-43 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11