FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF2612034TI0
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
26.120.34TI
Catalog number
26.120.34TI
Device description
PLASTIC INSTR. COMPOSITE FISSURE FORMER AND PLUGGER, INSERTS EXCHANGEABLE, BIONIK HANDLE BLACK, ONYX COATING
Published
2022-12-05
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
EKGCONDENSER, AMALGAM AND FOIL, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKGCondenser, Amalgam And Foil, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF2612034TI0PrimaryHIBCC0

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
+49742498880info@zepf-dental.com

Regulatory Flags#

DUNS number
320001431
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
EZPF2423001G0HELMUT ZEPF24.230.01G24.230.01G2026-04-13
EZPF2423001GM50HELMUT ZEPF24.230.01GM524.230.01GM52026-04-13
EZPF2423103G0HELMUT ZEPF24.231.03G24.231.03G2026-04-13
EZPF2423105G0HELMUT ZEPF24.231.05G24.231.05G2026-04-13
EZPF2423105GM50HELMUT ZEPF24.231.05GM524.231.05GM52026-04-13
EZPF2423105L0HELMUT ZEPF24.231.05L24.231.05L2026-04-13
EZPF2423411G0HELMUT ZEPF24.234.11G24.234.11G2026-04-13
EZPF2423411GM50HELMUT ZEPF24.234.11GM524.234.11GM52026-04-13
EZPF2423415G0HELMUT ZEPF24.234.15G24.234.15G2026-04-13
EZPF2423507G0HELMUT ZEPF24.235.07G24.235.07G2026-04-13
EZPF2423507GM50HELMUT ZEPF24.235.07GM524.235.07GM52026-04-13
EZPF2423609G0HELMUT ZEPF24.236.09G24.236.09G2026-04-13
EZPF2423713G0HELMUT ZEPF24.237.13G24.237.13G2026-04-13
EZPF2423713GM50HELMUT ZEPF24.237.13GM524.237.13GM52026-04-13
EZPF2423717G0HELMUT ZEPF24.237.17G24.237.17G2026-04-13
EZPF2423803L0HELMUT ZEPF24.238.03L24.238.03L2026-04-13
EZPF2423804S0HELMUT ZEPF24.238.04S24.238.04S2026-04-13
EZPF2423804SD0HELMUT ZEPF24.238.04SD24.238.04SD2026-04-13
EZPF2423806HF0HELMUT ZEPF24.238.06HF24.238.06HF2026-04-13
EZPF2423823A0HELMUT ZEPF24.238.23A24.238.23A2026-04-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G149TBSB4170TBS BASICSACME ENTERPRISE.EKG2026-05-20
G149TBSB4180TBS BASICSACME ENTERPRISE.EKG2026-05-20
G149TBSB4190TBS BASICSACME ENTERPRISE.EKG2026-05-20
10889950147242Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147259Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147266Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
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10889950147303Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147310Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
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10889950147334Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147341Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147358Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147365Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
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10889950147785Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147839Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147853Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147860Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147877Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950148447Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
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10889950019129HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKG2020-11-12