FDA.report

Safco polycarbonate crowns

Primary DI
D72310220560
Brand
Safco polycarbonate crowns
Company
SAFCO DENTAL SUPPLY CO.
Model
1022056
Catalog number
1022056
Device description
Safco polycar crwn bcspd/molr 120crwn
Published
2021-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ELZCROWN, PREFORMED

Product Code Classifications

CodeDeviceSpecialtyClass
ELZCrown, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D72310220563PrimaryHIBCC0
D72310220560Unit of UseHIBCC0

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 of a baby/child (primary tooth) or post-pubescent/adult patient (permanent tooth) to serve as a temporary device, typically until the natural tooth falls out or until the fitting of a permanent crown (not included). This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury.

Sterilization Methods

Method

Regulatory Flags

DUNS number
020417380
Device count
120
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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