FDA.reportPublic FDA data

KOHDENT

Primary DI
04251436926808
Brand
KOHDENT
Company
Kohler Medizintechnik GmbH
Model
7642
Catalog number
7642
Device description
PA-File - TRINOVO - Hirschfeld no.3/7
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
04251436926808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251436926808042514369268084251436926808

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal file/rasp, manualA hand-held manual dental instrument that has various forms of ridged cutting surfaces at its working end(s) designed to scrape and smooth during a periodontal procedure. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This device is typically used to remove gross supragingival calculus, smooth the cementoenamel junction (CEJ), and remove overhanging margins of dental restorations. 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