FDA.report

Hahnenkratt

Primary DI
E2068X70
Brand
Hahnenkratt
Company
E. Hahnenkratt GmbH
Model
8X7
Device description
Ivory for 7 mm wide bands
Published
2024-09-09
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

Product Codes

CodeName
JEPRetainer, Matrix

Product Code Classifications

CodeDeviceSpecialtyClass
JEPRetainer, MatrixDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E2068X70PrimaryHIBCC0

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

Regulatory Flags

DUNS number
316001098
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
E20640X151E. Hahnenkratt GmbH40X1502024-09-05
E20641X111Hahnenkratt41X112024-09-10
E20641X131Hahnenkratt41X132024-09-10
E20641X51Hahnenkratt41X52024-09-10
E206420010Hahnenkratt 420012024-09-10
E206420020 Hahnenkratt 420022024-09-10
E206420030Hahnenkratt 420032024-09-10
E206420050 Hahnenkratt420052024-09-10
E206420100Hahnenkratt 420102024-09-10
E206421000 Hahnenkratt 421002024-09-10
E206423111 Hahnenkratt 423112024-09-10
E20642311C31 Hahnenkratt 42311C32024-09-10
E20642311C51 Hahnenkratt42311C52024-09-10
E206423121 Hahnenkratt 423122024-09-10
E20642312C31 Hahnenkratt 42312C32024-09-10
E20642312C51Hahnenkratt 42312C52024-09-10
E206423131Hahnenkratt 423132024-09-10
E20642313C31 Hahnenkratt 42313C32024-09-10
E20642313C51Hahnenkratt42313C52024-09-10
E206423141 Hahnenkratt 423142024-09-10

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
00686864061151MEDICOM SAFEMATRIXAMD Medicom IncJEP2025-03-18
10840326423858AstekYoung Innovations, Inc.JEP2025-03-17
10840326423865AstekYoung Innovations, Inc.JEP2025-03-17
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