Facility

PRISMATIK DENTALCRAFT, INC.

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

Key facts

4recalls · worst Class II

1inspections · worst VAI

—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)	3011649314
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	2144 Michelson Drive Irvine, CA, US 92612
Registration status	Active · expires 2026
Parent company	PRISMATIK DENTALCRAFT, INC. (owner-operator 10043585)
Brand names	Inclusive Titanium Scanning Abutment Screw c/w: Straumann Tissue Level RN/WN synOcta; Inclusive Titanium Scanning Abutment Screw c/w: Straumann Bone Level NC/RC; Titanium Basal Screw (5-pack) compatible with: Straumann Tissue Level RN/WN synOcta; Inclusive Titanium Abutment 6 mmH c/w: Straumann Tissue Level WN synOcta; Inclusive Titanium Abutment Blank compatible with: Straumann Tissue Level RN synOcta; Inclusive Titanium Abutment 6 mmH c/w: Straumann Tissue Level RN synOcta; Inclusive Titanium Abutment 4.5 mmH c/w: Straumann Tissue Level RN synOcta; Inclusive GL Titanium Abutment 6 mmH compatible with: Straumann Tissue Level RN synOcta; Inclusive Titanium Abutment Blank compatible with: Straumann Tissue Level WN synOcta; Inclusive Titanium Abutment 4.5 mmH c/w: Straumann Tissue Level WN synOcta; Inclusive GL Titanium Abutment 4.5 mmH compatible with: Straumann Tissue Level RN synOcta; Inclusive Multi-Unit Abut. 1 mmH compatible with: Straumann RN synOcta

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (1)

Abutment, Implant, Dental, Endosseous
Product code NHA (opens in a new tab) · Class II · Dental · 21 CFR 872.3630

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.

FDA inspections (1)

VAI2017-09-13
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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 3011649314) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011649314-prismatik-dentalcraft-inc/

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