FDA.reportPublic FDA data

Hahnenkratt

Primary DI
E20644X1021
Brand
Hahnenkratt
Company
E. Hahnenkratt GmbH
Model
44X102
Device description
144-Pack: Tofflemire No. 102
Published
2024-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
E20644X1021PrimaryHIBCC0
E20644X1020Unit 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
144
Premarket exempt
true
Lot or batch
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850056330565White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330572White BiteWhite Bite, Inc.KCQ2025-10-27