Luminesse PMMA— 510(k) K142371

Clearance details

Applicant

Talladium, Inc.

Product code

Code EBG

Device class

Class 2

Regulation

21 CFR 872.3770

Advisory panel

Dental

Date received

2014-08-25

Decision date

2015-04-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Valencia, CA, US

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• K143090 — LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID2015-06-15
• K140848 — LUMINESSE PORCELAIN SYSTEM2014-12-17
• K100232 — LUMINESSE ZR BLANKS2010-05-21

• Z-0512-2021 — Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on the order of a dental professional.Class III·Terminated·Talladium Inc·20201009

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142371.