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Ceramill® Zolid

FDA UDI

Class II (US FDA UDI)

by Amann Girrbach AG

Identity

Trade Name
Ceramill® Zolid FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Model / Reference
Zolid fx PS bleach 71 S (14mm) FDA UDI

Identifiers

Catalog Number
761501 FDA UDI
Primary DI / UDI-DI
E4947615011 FDA UDI
510(k) Number
K152383 FDA UDI
FDA Product Code
EIH FDA UDI
GMDN Term
Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.6660 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Ceramill® Zolid by Amann Girrbach AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K152383 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Amann Girrbach AG

Sources (1)

  • FDA UDI be088f0d-7de1-446b-b0f9-9cd5956b8821 36 fields · synced Jun 1, 2026