• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
1 1

FDA 510(k) K151123, Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film, by Pac-Dent International, Inc.

FDA 510(k) K151123, Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film, by Pac-Dent International, Inc.

$89.00 USD
$89.00 USD
Sale Sold out
510(K) Number: K151123
Device Name: Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
Manufacturer: Pac-Dent International, Inc.
Device Classification Name: Dental Barriers And Sleeves
Regulation Number: PEM
Classification Product Code: KXA
Date Received: 04/28/2015
Decision Date: 03/03/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
View full details
FOIA Pro

This drug has a lot more FDA history than one product page can show

FOIA Pro gives you full-text search across 70,000+ FDA FOIA records, from 2020 through today, plus a monthly monitor tracking new requests as they close.
  • Full-text search across every FDA FOIA log since 2020
  • Warning letters, approval records, and correspondence in one place
  • Monthly FDA FOIA Monitor newsletter, included
  • Cancel anytime, monthly or annual billing
Get FOIA Pro
Live search · FOIA database
Searching related FDA records…
ClosedTypeSubjectOutcome