HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)— 510(k) K123273

Name: FDA 510(k) clearance K123273
Creator: U.S. Food and Drug Administration
Published: 2012-12-07

Substantially Equivalent

Temrex Corp.

FDA 510(k) clearance K123273 for HOFFMANN'S CEMENT (PHOSPHATE, NORMAL), Substantially Equivalent on 2012-12-07. Applicant: Temrex Corp.. Device class: 2.

Clearance details

Applicant: Temrex Corp.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2012-10-19
Decision date: 2012-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freeport, NY, US

Download summary PDF View on FDA.gov ↗

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