Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027248132

FEI Number

3027248132

Entity Name

Prismatik Dentalcraft, Inc.

City/State/Country

Irvine, CA, US

Establishment Address

17466 DAIMLER STREET, Irvine, CA 92614, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PRISMATIK DENTALCRAFT, INC. (Owner Number: 10043585)

Owner / Operator Contact Address

2144 Michelson Drive, Irvine, CA 92612, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BruxZir Brown Polishing Cup, 3/Pk BruxZir Green Polishing Cup (3-pack) BruxZir Adjustment and Polishing Kit BruxZir Brown Polishing Cup (3-pack) BruxZir Green Polishing Cup, 3/Pk BruxZir White Polishing Cup, 3/Pk BruxZir Blue Polishing Disc (3-pack) Refill BruxZir Green Brown White Polishing Cup (3-pack) BruxZir Adjustment & Polishing Kit BruxZir Brown Polishing Disc, 3/Pk BruxZir Polishing Cup set, 3/Pk BruxZir Brown Polishing Disk (3-pack) Refill BruxZir Blue Polishing Disc, 3/Pk BruxZir White Polishing Cup (3-pack) BruxZir Adjustment & Polishing Kit BruxZir Diamond Football Bur, 3/Pk BZ Round Football Tapered Burs (3-pack) BruxZir® Diamond football Bur (3-pack) BruxZir® Round Bur 018mm (3-pack) BruxZir Tapered Bur (021 mm), 3/Pk BruxZir Round Bur (018 mm), 3/Pk BruxZir® Tapered Bur- 021mm (3-pack) BruxZir Bur Set 3/Pk

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2023-04-05
EJL	Bur, Dental	Dental	Class 1	872.3240	2013-03-05

Official Correspondent

Michelle Gallup

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PRISMATIK DENTALCRAFT, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011649314	PRISMATIK DENTALCRAFT, INC.	Irvine, CA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027248132. Last updated year: 2026. Please use registration number 3027248132 when referencing this establishment in official correspondence.