Acero Crowns XT Molar

FDA UDI

Class I (US FDA UDI)

by Park-Istre, Llc.

Identity

Trade Name: Acero Crowns XT Molar FDA UDI
Generic Name: Preformed dental crown, temporary FDA UDI
Model / Reference: XT L2 FDA UDI

Identifiers

Primary DI / UDI-DI: 00810120874180 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

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

Category: Preformed dental crown, temporary

Acero Crowns XT Molar by Park-Istre, Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Park-Istre, Llc.

Sources (1)

FDA UDI b5d736ca-c8d3-4718-9e31-4d38db21705a 32 fields · synced Jun 1, 2026