Ceramir Pediatric Crown Start Kit Complete

FDA UDI

Class I (US FDA UDI)

by edelweiss dentistry products gmbh

Identity

Trade Name: Ceramir Pediatric Crown Start Kit Complete FDA UDI
Generic Name: Custom-made dental crown, polymer FDA UDI
Device Name: Toolbox with content 80 x Ceramir Pediatric Crowns (1 of each item), 1x Veneer Bond, 1x Each Size guide FDA UDI
Model / Reference: 805180 FDA UDI
Description: Toolbox with content 80 x Ceramir Pediatric Crowns (1 of each item), 1x Veneer Bond, 1x Each Size guide FDA UDI

Identifiers

Primary DI / UDI-DI: 09120046325675 FDA UDI
FDA Product Code: ELZ FDA UDI
EBF FDA UDI
GMDN Term: Custom-made dental crown, polymer FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3330 FDA UDI
872.3690 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental composite resin Custom-made dental crown, polymer

Ceramir Pediatric Crown Start Kit Complete by edelweiss dentistry products gmbh — 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: edelweiss dentistry products gmbh

Sources (1)

FDA UDI 4ae45fbc-a3b4-459f-8838-1ec5f99f3a89 33 fields · synced Jun 1, 2026