Facility

Prismatik Dentalcraft, Inc.

4 recall(s) on record — most severe on record: Class II.

Key facts

4recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3027248132
Establishment type	Manufacture Medical Device
Location	17466 DAIMLER STREET Irvine, CA, US 92614
Registration status	Active · expires 2026
Parent company	PRISMATIK DENTALCRAFT, INC. (owner-operator 10043585)
Brand names	BruxZir Adjustment & Polishing Kit; BruxZir Bur Set 3/Pk; BruxZir Round Bur (018 mm), 3/Pk; BruxZir® Tapered Bur- 021mm (3-pack); BZ Round Football Tapered Burs (3-pack); BruxZir® Diamond football Bur (3-pack); BruxZir Diamond Football Bur, 3/Pk; BruxZir Tapered Bur (021 mm), 3/Pk; BruxZir® Round Bur 018mm (3-pack)

Activity by year

Recalls (4)

Devices registered here (1)

Bur, Dental
Product code EJL (opens in a new tab) · Class I · Dental · 21 CFR 872.3240

Recalls & enforcement

Class IIOngoing2026-04-27
Due to device not having FDA Clearance
Class IIOngoing2025-09-30
Incorrect titanium screw, packaged with dental implant.
Class IIOngoing2025-04-14
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Class IITerminated2016-08-15
Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly identify the lots as quarantined product.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Prismatik Dentalcraft, Inc. (FEI 3027248132) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3027248132-prismatik-dentalcraft-inc/

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