FDA.reportPublic FDA data

KOHDENT

Primary DI
04251436904646
Brand
KOHDENT
Company
Kohler Medizintechnik GmbH
Model
3116
Catalog number
3116
Device description
PA-Probes CP-12 round-handle
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
04251436904646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251436904646042514369046464251436904646

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
04251436904936KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905032KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905049KOHDENTKohler 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