BruxZir 70-1175-BZA0015

by Prismatik Dentalcraft, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 24 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD745701175BZA00151 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: BruxZir
Generic Name: Dental appliance fabrication material, ceramic
Model / Ref / Catalog: 70-1175-BZA0015

Primary DI / UDI-DI: D745701175BZA00151
510(k) Number: K143330
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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Class I
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Class I
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Class I
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Class I

See all devices from Prismatik Dentalcraft, Inc. →

Properties

Single Use
Prescription Use
Lot / Batch Number
Manufacturing Date

Other properties (10)

Sterile: 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