FDA.report

Hahnenkratt

Primary DI
E20641X61
Brand
Hahnenkratt
Company
E. Hahnenkratt GmbH
Model
41X6
Device description
100-Pack: Nyström No. 6
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
true

Related Records

Product Codes

CodeName
KCQTube Impression And Matrix

Product Code Classifications

CodeDeviceSpecialtyClass
KCQTube Impression And MatrixDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E20641X61PrimaryHIBCC0
E20641X60Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental matrix band, reusableA band or strip of strong material (typically stainless steel or transparent polyester) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is held snugly around the tooth by a matrix retainer or tensioned around the tooth using a dedicated mechanical tensioning device. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
316001098
Device count
100
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
008101265033053D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKCQ2025-12-16
008101265062143D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKCQ2025-12-16
00197998465239Solventum US LLCSolventum US LLCKCQ2025-06-30
E20641X111HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-10
E20641X131HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-10
E20641X51HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-10
E20642X1131HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-10
E20641X1011HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20641X1021HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20641X11E. Hahnenkratt GmbHE. Hahnenkratt GmbHKCQ2024-09-09
E20641X1131HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20641X121HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20641X141HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20641X1501HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20641X151HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20641X1511HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20641X161HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20641X21E. Hahnenkratt GmbHE. Hahnenkratt GmbHKCQ2024-09-09
E20641X31E. Hahnenkratt GmbHE. Hahnenkratt GmbHKCQ2024-09-09
E20641X41E. Hahnenkratt GmbHE. Hahnenkratt GmbHKCQ2024-09-09
E20641X71HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20642X1011HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20642X1021HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20642X1031HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20644X1011HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20644X1021HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20644X1031HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20644X1131HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20660X1011HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09
E20660X1021HahnenkrattE. Hahnenkratt GmbHKCQ2024-09-09