FDA.report

3M™ Cavit™

Primary DI
04035077218320
Brand
3M™ Cavit™
Company
3M Deutschland GmbH
Model
44350
Catalog number
44350
Device description
3M™ Cavit™ Temporary Filling Material, 44350, 10 - 7g Tubes, W
Published
2023-09-22
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
EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04064035111915PrimaryGS10
04035077218320Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04064035111915040640351119154064035111915
04035077218320040350772183204035077218320

GMDN Terms

TermDefinition
Fatty acid dental cementA non-sterile, non-aqueous substance containing fatty acids typically with a mixture of oxides or hydroxides of zinc, magnesium, and/or calcium, that cures upon the acid/base reaction of its components and is intended to be used in a professional setting for the temporary luting of prefabricated dental crowns and bridges, but may also be used for the temporary filling of small cavities. It is typically available as a two-component device that can be hand mixed or auto-mixed (using a dispenser with mixing nozzle) into a paste. After application, this device cannot be reused.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)634-22493Mhealthcarecompliance@mmm.com

Regulatory Flags

DUNS number
315731711
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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