FDA.report

Medicon

Primary DI
04046826184469
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
379.08.10
Catalog number
379.08.10
Device description
Tofflemire matrix retainer cpl set
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
04046826184469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826184469040468261844694046826184469

GMDN Terms

TermDefinition
Dental matrix band retainerA dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration. It can be designed as a self-closing circular ring, or a rod-like instrument that tensions and locks the matrix band in place. This device will remain intraoral or attached to the matrix band during the dental procedure. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+490746220090sales@medicon.de

Regulatory Flags

DUNS number
315492330
Device count
1
DM exempt
true
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
false
Sterilization required before use
true

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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
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00810038091211Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091228Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
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00810038091242Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16