FDA.reportPublic FDA data

NuSmile ZR Narrow First Primary Molar Crowns Professional Kit

Primary DI
00810092936978
Brand
NuSmile ZR Narrow First Primary Molar Crowns Professional Kit
Company
NUSMILE, LTD.
Model
PKD207X
Device description
NuSmile ZR Narrow First Primary Molar Crowns Professional Kit - 84 Crowns, Extra Light Shade
Published
2021-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00810092936978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810092936978008100929369788100929369780810092936978

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
185497372
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810118108075NuSmile NuCemSNUCEM2026-04-21
08809911118505NuSmile NuCemNCRSK2026-04-14
08809911118512NuSmile NuCemNCRPK2026-04-14
00810118107962NuSmile Bite Stick / Band SeaterBS-0012026-04-08
00810118107979NuSmile Heavy Band PusherBP-0022026-04-08
00810118107986NuSmile 3 Jaw PlierTJP-0032026-04-08
00810118107993NuSmile Bird Beak PlierBBP-0042026-04-08
00810118108006NuSmile Band / Crown Crimping PlierBCP-0052026-04-08
00810118108013NuSmile Heavy Curved ScissorsHCS-0062026-04-08
00810118108020NuSmile Posterior Band RemoverPBR-0072026-04-08
00810118108037NuSmile Tube Crimping PlierTCP-0082026-04-08
00810118108044NuSmile Contouring PlierCP-0092026-04-08
00810118108051NuSmile Hard Wire CutterHWC-0102026-04-08
00810118107948NuSmile NuCemNCRSKI2026-04-08
00810118107955NuSmile NuCemNCRPKI2026-04-08
00810118108068Zarc by Avalon Biomed NanoShaper Gutta-Percha Assorted ZN1-ZN5 (Sample)SGP-N1992026-04-06
00810118107931NuSmile NuCemNCRPK2026-04-02
00810118107924NuSmile NuCemNCRSK2026-04-01
00810118103650Zarc by Avalon Biomed Gutta Perch Obturator (Pellets)63440032026-01-15
00810118105555Ultradent MTApex 5.0 g Powder138692026-01-14

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