FDA.report

3M™ ESPE™ Iso-Form™

Primary DI
50605861024278
Brand
3M™ ESPE™ Iso-Form™
Company
3M COMPANY
Model
U-70
Catalog number
U-70
Device description
3M™ ESPE™ Iso-Form™ Second Molar Replacement Crown, Upper Right, Size U-70, U70
Published
2018-09-24
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
true

Related Records

Contact Domains

Product Codes

CodeName
ELZCROWN, PREFORMED

Product Code Classifications

CodeDeviceSpecialtyClass
ELZCrown, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50605861024278PackageGS15In Commercial Distribution
30605861024274PrimaryGS10
00605861024273Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5060586102427850605861024278
3060586102427430605861024274
00605861024273006058610242736058610242730605861024273

GMDN Terms

TermDefinition
Preformed dental crown, temporaryA prefabricated tooth crown, usually made of stainless steel, aluminium (Al) or resin, that is designed to be fitted over a damaged or prepared tooth to serve as a temporary protective device. This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
830016148
Device count
5
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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