FDA.reportPublic FDA data

KOHDENT

Primary DI
04251436914379
Brand
KOHDENT
Company
Kohler Medizintechnik GmbH
Model
5278
Catalog number
5278
Device description
Elevatories Seldin No. 23 ( 19,5 cm )
Published
2021-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMRFILE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMRFile, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251436914379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251436914379042514369143794251436914379

GMDN Terms#

Term, Definition table
TermDefinition
Dental elevator, tooth/rootA hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497771649990info@kohler-medizintechnik.de

Regulatory Flags#

DUNS number
344386737
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251436919084Kohler6414-CC2026-04-23
04251436943850Kohler83142026-04-23
04251436909030KOHLER451645162026-03-12
04251436934155KOHLER451645162026-03-12
04251436931086KOHLER955795572026-03-12
04251436943805KOHLER842884282026-03-12
04251436943812KOHLER8461-CC8461-CC2026-03-12
04251436943836KOHLER8401-N8401-N2026-03-12
04251436943843KOHLER330833082026-03-12
04251436907746KOHDENT430643062021-08-30
04251436943492KOHDENT670067002023-11-28
04251436915819KOHDENT573957392021-09-22
04251436915826KOHDENT574057402021-09-22
04251436915833KOHDENT574157412021-09-22
04251436918094KOHDENT616361632021-09-22
04251436918100KOHDENT616661662021-09-22
04251436918179KOHDENT620962092021-09-22
04251436918186KOHDENT621062102021-09-22
04251436918834KOHDENT635863582021-09-22
04251436921209KOHDENT679267922021-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D9284004001CH0PERIO FILE SUGARMAN 1S D/E CH HANDLE SPECIAL DR SINW.H. Holden, Inc.EMR2026-03-18
D9284004002CH0PERIO FILE SUGARMAN 2S D/E CH HANDLE SPECIAL DR SINW.H. Holden, Inc.EMR2026-03-18
D928400400CH0PERIO FILE SUGARMAN 1S/2S D/E CH HANDLEW.H. Holden, Inc.EMR2026-03-18
D928400400HD0PERIO FILE SUGARMAN 1S/2S D/E HD HANDLEW.H. Holden, Inc.EMR2026-03-18
D928400400HF0PERIO FILE SUGARMAN 1S/2S D/E HF HANDLEW.H. Holden, Inc.EMR2026-03-18
D928400435RD0PERIO FILE SCHLUGER 9/10 D/E ROUND HANDLEW.H. Holden, Inc.EMR2026-03-18
00840018665767Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMR2026-02-09
00840018665774Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMR2026-02-09
00841336110854Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMR2024-12-11
00813677024756PDT, Inc.PDT, INC.EMR2024-05-22
00842517113688Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517118973Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517119048Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517119055Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517119109Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517106093Karl SchumacherKarl Schumacher Dental, LLCEMR2024-03-15
00842517106109Karl SchumacherKarl Schumacher Dental, LLCEMR2024-03-15
00842517106130Karl SchumacherKarl Schumacher Dental, LLCEMR2024-03-15
00841336101203Salvin Freer Periosteal ElevatorsSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336101227Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336102286Salvin Goldman-Fox Periosteal Elevator - 17cmSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336102385Salvin Molt 9SALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336102460Salvin West Periosteal ElevatorSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336102859Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336102866Salvin Bone File #12SALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336102873Salvin Bone File #10SALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336102880Salvin Bone File # 12CA Cross CutSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336102897Salvin Bone File # 10CA Cross CutSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336104150Salvin Molt #2 Single End InstrumentSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10
00841336104167Salvin Molt 4 Single End InstrumentSALVIN DENTAL SPECIALTIES, LLCEMR2023-08-10