FDA.reportPublic FDA data

KOHDENT

Primary DI
04251436933257
Brand
KOHDENT
Company
Kohler Medizintechnik GmbH
Model
8462
Catalog number
8462
Device description
Micro plugger, 3 mm, 0.6 mm dia. PENN ENDO CREATION
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
EIXPROBE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIXProbe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251436933257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251436933257042514369332574251436933257

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
10856364008100Florida ProbeFlorida Probe CorporationEIX2023-08-08
07898506811861QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811878QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811885QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811892QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811908QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811915QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811922QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506839414QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506843862QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506849239QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506849253QuinelatoSchobell Industrial LtdaEIX2022-12-08
07899798200258QuinelatoSchobell Industrial LtdaEIX2022-12-08
10889950034726HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034733HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
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10889950034764HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
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10889950034801HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034818HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034825HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034832HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034849HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034856HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
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10889950034870HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034887HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034894HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12