RADENT PROPHY PASTE— 510(k) K040661

Substantially Equivalent

Pascal Co., Inc.

FDA 510(k) clearance K040661 for RADENT PROPHY PASTE, Substantially Equivalent on 2004-06-09. Applicant: Pascal Co., Inc.. Device class: 1.

Clearance details

Applicant: Pascal Co., Inc.
Product code: Code EJR
Device class: Class 1
Regulation: 21 CFR 872.6030
Advisory panel: Dental
Date received: 2004-03-12
Decision date: 2004-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJR

K171189 — AIR-FLOW PLUS Prophylaxis powder2017-09-11
K131760 — WHIP MIX PREPPIES PLUS2014-03-26
K121698 — NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN2012-08-06
K103114 — OSSPRAY SYLC CR2011-03-14
K102053 — BUTLER CALCI-FLOR PROPHYLAXIS PASTE2011-02-03

More clearances from Pascal Co., Inc.

K102526 — BLO2X OXYGEN BLOCKER2010-10-22
K090597 — FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH2009-03-16
K040988 — ZIRCON-F PROPHYLAXIS PASTE2004-07-07
K012889 — BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT2003-05-27
K030488 — FLUORILAQ2003-05-02

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