Kids-e-crown

FDA UDI

Class I (US FDA UDI)

by Kids-E-Dental Llp

Identity

Trade Name: Kids-e-crown FDA UDI
Generic Name: Preformed dental crown, temporary FDA UDI
Device Name: Pediatric- Preformed zirconia crown Posterior Starter Kit containing 40 crowns FDA UDI
Model / Reference: KEC-PSK FDA UDI
Description: Pediatric- Preformed zirconia crown Posterior Starter Kit containing 40 crowns FDA UDI

Identifiers

Primary DI / UDI-DI: 08906154843062 FDA UDI
FDA Product Code: ELZ FDA UDI
GMDN Term: Preformed dental crown, temporary FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3330 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Preformed dental crown, temporary

Kids-e-crown by Kids-E-Dental Llp — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Preformed dental crown, temporary.

3M™ Unitek™ — 3M COMPANY · Class I
NuSmile BioFlx Anterior Central, Lateral and Cuspids - Professional Kit — NUSMILE, LTD · Class I
NuSmile Pre-Contoured Stainless Steel Cuspid Crown - Mandibular, Size 2 — NUSMILE, LTD · Class I
Acero Crowns XT Molar — PARK-ISTRE, LLC. · Class I
NuSmile ZR Posterior Replacement Crown — NUSMILE, LTD · Class I
NuSmile Pre-Contoured Stainless Steel Crown — NUSMILE, LTD · Class I
NuSmile ZR Posterior Replacement Crown - First Primary Molar Maxillary Right, Si — NUSMILE, LTD · Class I
NuSmile BioFlx Posterior Replacement Crown - First Primary Molar — NUSMILE, LTD · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Kids-E-Dental Llp

Sources (1)

FDA UDI 1b0926f4-646c-4c0a-882a-3d9096b4627c 33 fields · synced May 30, 2026