FDA.reportPublic FDA data

MK-dent

Primary DI
E490LU10311
Brand
MK-dent
Company
MK-Dent GmbH
Model
SERVICE OIL
Catalog number
LU1031
Device description
Lubricant for maintenance
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E490LU10311PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument maintenance lubricantA non-sterile solution intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument); it is not dedicated to a particular type of surgical instrument. It may be a water-soluble solution, commonly known as instrument milk because of its white colour when mixed with water, in which the instrument is immersed, or it may be a spray that is sprayed onto the instrument. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature0 Degrees Fahrenheit122 Degrees Fahrenheit
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature0 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
343618943
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
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
J021112458001RC-58 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11