FDA.reportPublic FDA data

KOHDENT

Primary DI
04251436905049
Brand
KOHDENT
Company
Kohler Medizintechnik GmbH
Model
3197
Catalog number
3197
Device description
Periodontal probe CP15 with TITANIUM tipand Zircon nitrid coating, TRINOVO
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
EMPMARKER, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMPMarker, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251436905049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251436905049042514369050494251436905049

GMDN Terms#

Term, Definition table
TermDefinition
Dental explorerA hand-held manual dental instrument designed for tactile examination (i.e., exploration) in the oral cavity, on the tooth surface and/or gums, mainly to find indentations (e.g., pits, fissures) for the determination of early tooth decay on the crown of teeth; it is also used in periodontology (e.g., to locate subgingival deposits before scaling). It is a long, slender instrument (a manual probe) with a stem that terminates in a thin working part at the distal end which may be needle-like, hooked, or blunt according to the intended use. 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
04251436943805KOHLERKohler Medizintechnik GmbHEMP2026-03-12
00841336108622Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMP2025-11-11
00860012076604UMarcNew Venture Enterprise Ltd.EMP2024-07-03
00860012076611UMarcNew Venture Enterprise Ltd.EMP2024-07-03
10860012076601UMarcNew Venture Enterprise Ltd.EMP2024-07-03
20860012076615UMarcNew Venture Enterprise Ltd.EMP2024-07-03
00841336101760Salvin Stainless Steel UNC ProbeSALVIN DENTAL SPECIALTIES, LLCEMP2023-08-21
00841336105430Perio Probe BlackSALVIN DENTAL SPECIALTIES, LLCEMP2023-08-10
00841336101791Salvin Titanium CP12 Perio ProbeSALVIN DENTAL SPECIALTIES, LLCEMP2023-07-31
00841336101807Salvin Titanium UNC-15 Perio ProbeSALVIN DENTAL SPECIALTIES, LLCEMP2023-07-31
10889950086527Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMP2023-04-07
00887919771371Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
00887919771432Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
00887919771463Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
00887919771494Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
04251436904646KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436904936KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905032KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905056KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905063KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436925818KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436925856KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436930621KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436931253KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436931260KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436933141KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
00840105217442ZOLL-DENTALZoll-DentalEMP2021-03-10
00840105217459ZOLL-DENTALZoll-DentalEMP2021-03-10
10381780450283Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEMP2018-02-26
10381780450290Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEMP2018-02-26