FDA.reportPublic FDA data

3M™ Unitek™

Primary DI
50605861027217
Brand
3M™ Unitek™
Company
3M COMPANY
Model
900127
Catalog number
900127
Device description
3M™ Unitek™ Stainless Steel First Primary Molar Crown, Upper Right, Size 7 (5/pack), 900127
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

Contact Domains#

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
50605861027217PackageGS15In Commercial Distribution
30605861027213PrimaryGS10
00605861027212Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5060586102721750605861027217
3060586102721330605861027213
00605861027212006058610272126058610272120605861027212

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

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
007073874985353M™ Cavilon™3344E3344E2022-12-08
007073877918893M™ Cavilon™3344ENS3344ENS2022-12-08
10608223630003Bair Hugger™63000630002016-09-24
10608223645007Bair Hugger™64500645002016-09-24
507073878140263M™ Ioban™8840EZ8840EZ2025-01-17
507073878140333M™ Ioban™8850EZ8850EZ2025-01-17
307073878140463M™ Ioban™8851EZ8851EZ2025-01-17
507073878140573M™ Ioban™8840EZSB8840EZSB2025-01-17
507073878140643M™ Ioban™8850EZSB8850EZSB2025-01-17
507073878140713M™ Ioban™8851EZSB8851EZSB2025-01-17
507073875674653M™861186112026-02-19
507073877738733M™861086102026-02-19
506058610858733M™6550A16550A12025-09-09
506058610858803M™6550A26550A22025-09-09
506058610858973M™6550A36550A32025-09-09
506058610859033M™6550A3.56550A3.52025-09-09
506058610859103M™6550A46550A42025-09-09
506058610859273M™6550B16550B12025-09-09
506058610859343M™6550B26550B22025-09-09
506058610859413M™6550D36550D32025-09-09

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