FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF19080120
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
19.080.12
Catalog number
19.080.12
Device description
SETTER, BAND EASY MATRIX SETTER 12CM, 90° CURVED
Published
2022-11-29
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
ECRSETTER, BAND, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECRSetter, Band, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF19080120PrimaryHIBCC0

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
00860014476143SmileSet Aligner/Retainer Seater/Removal ToolOrtho Dental Lab LLCECR2025-10-16
00850078989321SmileSet Aligner/Retainer Seater/Removal Tool – 4 PackOrtho Dental Lab LLCECR2025-10-01
00889813063699Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCECR2024-11-30
00813677022967PDT, Inc.PDT, INC.ECR2024-07-05
00813677022974PDT, Inc.PDT, INC.ECR2024-07-05
00840326420836Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420843Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420928Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420935Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420942Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420959Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420833Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420840Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420925Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420932Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420949Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420956Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
D1272421031Artman Instruments Wise Linkers, LLCECR2023-03-28
E89656540SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-07
E8965654500SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-07
E896495010SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-06
00817524028805J&J InstrumentsJ & J INSTRUMENTS INCECR2023-03-01
00817524028812J&J InstrumentsJ & J INSTRUMENTS INCECR2023-03-01
00850007728410ALIGNER SEATER PURPLEAccess Dental Lab, LLCECR2023-02-17
EZPF1926200WL0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHECR2022-11-25
00840326408773OrthoquestYoung Innovations, Inc.ECR2022-11-03
00840326408803OrthoquestYoung Innovations, Inc.ECR2022-11-03
10840326408770OrthoquestYoung Innovations, Inc.ECR2022-11-03
10840326408800OrthoquestYoung Innovations, Inc.ECR2022-11-03
04963931227037NAYDM CORPORATIONECR2022-09-30