Cleared Traditional

K952234 - BARRIER ALL FILM

K952234 is an FDA 510(k) clearance for BARRIER ALL FILM, manufactured by Cottrell, Ltd.. The device is a Class 1 Dental device with product code EFS cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K952234 · Cottrell, Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
80d
Days
Class 1
Risk

K952234 is an FDA 510(k) clearance for the BARRIER ALL FILM. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by Cottrell, Ltd. (North Attleboro, US). The FDA issued a Cleared decision on July 31, 1995 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6510 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K952234

510(k) Number K952234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1995
Decision Date July 31, 1995
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 128d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

EFS Device Classification - Class 1, General Controls

Product Code EFS Unit, Oral Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6510
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFS Unit, Oral Irrigation

All 26
Devices cleared under the same product code (EFS) and FDA review panel - the closest regulatory comparables to K952234.
DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001
K001493 · Air Force, Inc. · Oct 2000
AGATHA-A-H2010
K983374 · Midian Intl. · Dec 1998
DERMADAM
K964810 · Ultradent Products, Inc. · Feb 1997
ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR
K943182 · Oral-B Laboratories · Sep 1994
PERIOFLEX TIP
K923711 · Novadent, Ltd. · May 1994
HYDRO FLOSS
K923937 · Hydro Floss, Inc. · Feb 1994
K952234 · BARRIER ALL FILM
Download PDF FDA Summary Cottrell, Ltd.