FDA.reportPublic FDA data

Safco polycarbonate crowns

Primary DI
D72310265500
Brand
Safco polycarbonate crowns
Company
SAFCO DENTAL SUPPLY CO.
Model
1026550
Catalog number
1026550
Device description
Safco strip-off crown #D2 med/sm 6.25
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

Product Codes#

Code, Name table
CodeName
ELZCROWN, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELZCrown, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D72310265503PrimaryHIBCC0
D72310265500Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
020417380
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20810063756240KIDS BUDDY Toothbrush8250071TK32025-03-19
20810063756257Power Curve Toothbrush82500830022025-03-19
20810063756264Esprit Ultra Fine Toothbrush82500872082025-03-19
20810063756271Whisper Tech Ultra-Fine Toothbrush82500926012025-03-19
20810063756288Power Curve Toothbrush8250093002-I2025-03-19
20810063756400Power Curve Extra-Soft Toothbrush8250094002XS2025-03-19
20810063756431KIDS BUDDY Toothbrush8250072TK3-I2025-03-19
20810063756585Jr Series Comfort Grip Toothbrush82500892402025-03-19
20810063756592Power Curve Extra-Soft Toothbrush8250095002XS-I2025-03-19
20810063755564Waxed Dental Floss8250016300062025-03-18
20810063756172Euro Tech Compact Sensitive Toothbrush8250007T1872025-03-18
20810063756189Waxed Dental Floss8250017300072025-03-18
20810063756196Floss Picks8250039FP2025-03-18
20810063756202Endeavor Toothbrush8250043T0202025-03-18
20810063756219Vital Fresh Toothbrush8250048T056-I2025-03-18
20810063756226Aspire Compact Toothbrush8250060T509-I2025-03-18
20810063756233PlaquePRO Interdental Proxy Brush8250066T5132025-03-18
20810063756394Polisher Compact Toothbrush8250058T4902025-03-18
20810063756530Soft Flex Toothbrush8250054T183-I2025-03-18
20810063756547Glisten Junior Toothbrush8250064T511-I2025-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810118106644NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106651NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106682NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106842NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106859NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106866NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106873NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106880NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106897NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106903NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106910NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106927NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106934NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106941NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106958NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106965NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106972NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106989NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106996NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107009NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107016NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107023NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107030NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107047NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107054NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107061NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107078NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107085NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107092NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107108NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26