Fresco Dentine B4 (10 g) KEAD0901

by Zirkonzahn GmbH 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD800KEAD09010 UDI-DI	Date25 May 2023Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Fresco Dentine B4 (10 g)
Generic Name: Dental appliance fabrication material, ceramic
Model / Reference: KEAD0901

Primary DI / UDI-DI: D800KEAD09010
FDA Product Code: EIH
GMDN Term: Dental appliance fabrication material, ceramic

Device Class: Class II
Regulation Number: 872.6660
GUDID distribution status: In Commercial Distribution

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Properties

Prescription Use
Lot / Batch Number
Manufacturing Date

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No