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BruxZir

FDA UDI

Class II (US FDA UDI)

by Prismatik Dentalcraft, Inc.

Identity

Trade Name
BruxZir FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Device Name
BruxZir Shaded-16 D4 1-Pack GD 12mm D FDA UDI
Model / Reference
70-1138-BSA0725 FDA UDI
Description
BruxZir Shaded-16 D4 1-Pack GD 12mm D FDA UDI

Identifiers

Catalog Number
70-1138-BSA0725 FDA UDI
Primary DI / UDI-DI
D745701138BSA07250 FDA UDI
510(k) Number
K130924 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

No

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Height — 12 Millimeter FDA UDI

BruxZir by Prismatik Dentalcraft, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K130924 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Prismatik Dentalcraft, Inc.

Sources (1)

  • FDA UDI e20da6b4-c16c-4b18-a668-3d5dd979cef9 38 fields · synced Jun 6, 2026