FDA.report

tofflemire transparent matrices

Primary DI
E29959369
Brand
tofflemire transparent matrices
Company
Polydentia SA
Model
5936
Device description
0.075 mm/ 5.5 mm, 50 pcs.
Published
2022-07-05
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

Contact Domains

Product Codes

CodeName
DZNInstruments, Dental Hand

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E29959360PrimaryHIBCC0
E29959369Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental matrix band, single-useA band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+41919462948info@polydentia.ch

Regulatory Flags

DUNS number
481461598
Device count
50
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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