FDA.report

Protemp™ Plus

Primary DI
04035077004251
Brand
Protemp™ Plus
Company
3M Deutschland GmbH
Model
46955
Catalog number
46955
Device description
3M™ ESPE™ Protemp™ Plus Temporization Material Refill A1, 46955
Published
2017-08-04
Public version status
Update
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
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04035077004251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04035077004251040350770042514035077004251

GMDN Terms

TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
315731711
Device count
1
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
false
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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