FDA.report

KOHDENT

Primary DI
04251436909443
Brand
KOHDENT
Company
Kohdent Roland Kohler Medizintechnik GmbH & Co. KG
Model
4540-DOYEN 14
Catalog number
4540-DOYEN 14
Device description
Probes DOYEN 14 cm
Published
2021-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EKBEXPLORER, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKBExplorer, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04251436909443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04251436909443042514369094434251436909443

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497771649990info@kohler-medizintechnik.de

Regulatory Flags

DUNS number
324006097
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00348783005929Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783005974Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783005998Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006018Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006056Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006063Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006186Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006223Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
G149TBSEXP111201TBS DentalACME ENTERPRISE.EKB2026-03-02
00840018673229Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-11
00840018674127Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-11
00840018667150Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-10
00840018666108Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-09
00840018663688Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-04
00840018664012Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-04
08800019151548Endodontic ExplorerB& L Biotech, inc.EKB2025-04-30
EZPF2474460HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEKB2025-03-07
EZPF2474465HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEKB2025-03-07
00889813065242Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-12-18
00889813065303Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-12-18
00889813065143Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-12-12
00889813065266Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-12-12
00889813065136Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065150Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065174Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065181Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065198Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065204Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065228Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065235Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30