FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040054956
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1004232
Catalog number
1004232
Device description
Polycarbonate Crowns
Published
2020-08-24
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

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
10304040054953PrimaryGS10
00304040054956Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404005495310304040054953
00304040054956003040400549563040400549560304040054956

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 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 table
Method

Regulatory Flags#

DUNS number
012430880
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
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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