FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF33770250
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
33.770.25
Catalog number
33.770.25
Device description
BRACKET REMOVING PLIERS WITH PLASTIC INSERT, MADE OF FORGED HIGH CARBON STEEL
Published
2025-03-07
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
JEXPLIER, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEXPlier, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF33770250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wire holding/twisting pliersA heavy-duty manual surgical instrument with specially-designed sturdy handles and blade jaws used to grip, tighten, and/or twist wires during a surgical intervention. It has a scissors-like design with curved handles and is made of high-grade stainless steel. It is available in various sizes and the jaws (typically short and broad with serrations) at the working end are activated through a single pivot or a double ratio-lever exchange pivot to provide greater gripping force. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791050070DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-09-30
G8791052360DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-09-30
04963931274673NAYDM CORPORATIONJEX2026-09-25
04963931274680NAYDM CORPORATIONJEX2026-09-25
G8791031420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791031430DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050010DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050660DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050670DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050680DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050770DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050810DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050850DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G879105085M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050890DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050950DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050960DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050980DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050990DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051040DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051390DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G87910513910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051440DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051530DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051590DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G87910515910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791052160DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14