FDA.reportPublic FDA data

Hahnenkratt

Primary DI
E20641X51
Brand
Hahnenkratt
Company
E. Hahnenkratt GmbH
Model
41X5
Device description
100-Pack: Nyström No. 5
Published
2024-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KCQTube Impression And Matrix

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCQTube Impression And MatrixDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E20641X51PrimaryHIBCC0
E20641X50Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316001098
Device count
100
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E206103440Hahnenkratt103442024-12-20
E20640X1501E. Hahnenkratt GmbH40X1502024-12-20
E20640X161E. Hahnenkratt GmbH40x162024-12-20
E20641X1031Hahnenkratt41X1032024-12-20
E206B4420HahnenkrattB4422024-12-20
E206B4430HahnenkrattB4432024-12-20
E20640X151E. Hahnenkratt GmbH40X1502024-09-05
E20641X111Hahnenkratt41X112024-09-10
E20641X131Hahnenkratt41X132024-09-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850075846108White BiteWhite Bite, Inc.KCQ2026-05-27
00850075846122White BiteWhite Bite, Inc.KCQ2026-05-27
008101265033053D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKCQ2025-12-16
008101265062143D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKCQ2025-12-16
00850056330008White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330015White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330022White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330039White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330046White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330053White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330060White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330077White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330084White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330091White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330107White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330114White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330121White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330138White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330145White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330152White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330169White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330176White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330183White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330206White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330220White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330237White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330244White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330251White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330541White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330558White BiteWhite Bite, Inc.KCQ2025-10-27