FDA.report

HELMUT ZEPF

Primary DI
EZPF19062000
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
19.062.00
Catalog number
19.062.00
Device description
MATRIX RETAINER, TOFFLEMIRE - SENIOR,
Published
2022-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JEPRETAINER, MATRIX

Product Code Classifications

CodeDeviceSpecialtyClass
JEPRetainer, MatrixDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EZPF19062000PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental matrix band tensionerA hand-held, dental instrument designed for tightening a matrix band around a tooth that is being prepared for a dental restoration. It is a rod-like device, typically designed with a manually controlled rotating action at its distal end for insertion into and tightening of a retainerless matrix band around the tooth. When the matrix band is in place, this device is removed offering a clear field of vision. Some types may incorporate a torque control mechanism to limit over-tensioning. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+49742498880info@zepf-dental.com

Regulatory Flags

DUNS number
320001431
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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EZPF3375001F0HELMUT ZEPF33.750.01F33.750.01F2025-03-10
EZPF33750020HELMUT ZEPF33.750.0233.750.022025-03-10
EZPF33760020HELMUT ZEPF33.760.0233.760.022025-03-10
EZPF33760030HELMUT ZEPF33.760.0333.760.032025-03-10
EZPF33760110HELMUT ZEPF33.760.1133.760.112025-03-10
EZPF33760200HELMUT ZEPF33.760.2033.760.202025-03-10
EZPF33760210HELMUT ZEPF33.760.2133.760.212025-03-10
EZPF1704503HZU0HELMUT ZEPF17.045.03HZU17.045.03HZU2025-03-07
EZPF1742301HZU0HELMUT ZEPF17.423.01HZU17.423.01HZU2025-03-07
EZPF1742302HZU0HELMUT ZEPF17.423.02HZU17.423.02HZU2025-03-07
EZPF2474403LM5HZU0HELMUT ZEPF24.744.03LM5-HZU24.744.03LM5-HZU2025-03-07
EZPF2474405GHZU0HELMUT ZEPF24.744.05G-HZU24.744.05G-HZU2025-03-07
EZPF2474408HZU0HELMUT ZEPF24.744.08HZU24.744.08HZU2025-03-07
EZPF2474411GHZU0HELMUT ZEPF24.744.11G-HZU24.744.11G-HZU2025-03-07
EZPF2474413GHZU0HELMUT ZEPF24.744.13G-HZU24.744.13G-HZU2025-03-07
EZPF2474455HZU0HELMUT ZEPF24.744.55HZU24.744.55HZU2025-03-07
EZPF2474460HZU0HELMUT ZEPF24.744.60HZU24.744.60HZU2025-03-07
EZPF2474465HZU0HELMUT ZEPF24.744.65HZU24.744.65HZU2025-03-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
008101265081643D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
008101265081713D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
008101265081883D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
008101265081953D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
00840456215227Generic Packing (No Brand)JMU DENTAL, INCJEP2025-08-18
00840456215234Generic Packing (No Brand)JMU DENTAL, INCJEP2025-08-18
00840456213537JMUJMU DENTAL, INCJEP2025-06-25
00840456213544JMUJMU DENTAL, INCJEP2025-06-25
00840456213551JMUJMU DENTAL, INCJEP2025-06-25
00840456213568JMUJMU DENTAL, INCJEP2025-06-25
00850056330718White BiteWhite Bite, Inc.JEP2025-06-10
00850056330701White BiteWhite Bite, Inc.JEP2025-05-16
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10840326423872AstekYoung Innovations, Inc.JEP2025-03-17
10840326423889AstekYoung Innovations, Inc.JEP2025-03-17
00810038091129Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091136Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091143Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091150Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091167Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091174Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091181Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091198Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091204Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091211Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091228Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091235Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091242Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16