PEKALUX(TM)— 510(k) K872243

Substantially Equivalent

Columbus Dental Mfg. Co.

FDA 510(k) clearance K872243 for PEKALUX(TM), Substantially Equivalent on 1987-07-07. Applicant: Columbus Dental Mfg. Co.. Device class: 2.

Clearance details

Applicant: Columbus Dental Mfg. Co.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1987-06-11
Decision date: 1987-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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More clearances from Columbus Dental Mfg. Co.

K880754 — DRI-CLAVE LIQUID KLEENZALL1988-05-12
K880607 — UTILITY WAX STRIPS, SPEARMINT1988-03-31
K880606 — UTILITY WAX STRIPS, CINNAMON1988-03-24
K871164 — GLUMA(TM) BONDING SYSTEM1987-07-02
K872272 — PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS1987-07-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.