Cleared Traditional

K943182 - ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR

K943182 is an FDA 510(k) clearance for ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR, manufactured by Oral-B Laboratories. The device is a Class 1 Dental device with product code EFS cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K943182 · Oral-B Laboratories · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
70d
Days
Class 1
Risk

K943182 is an FDA 510(k) clearance for the ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by Oral-B Laboratories (Redwood City, US). The FDA issued a Cleared decision on September 9, 1994 after a review of 70 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.

View all Oral-B Laboratories devices

FDA 510(k) Submission Details - K943182

510(k) Number K943182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1994
Decision Date September 09, 1994
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
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

Devices cleared under the same product code (EFS) and FDA review panel - the closest regulatory comparables to K943182.
DERMADAM
K964810 · Ultradent Products, Inc. · Feb 1997
INTERJET(TM) GINGIVAL CARE INSTRUMENT
K921999 · Bausch & Lomb, Inc. · Jun 1992
MAX-I-PROBE IRRIGATION SYSTEM
K913030 · Smith & Nephew, Inc. · Sep 1991
PERIODONTAL SCALING SOLUTION-A
K875132 · Dentsply Intl. · Feb 1988
PERIDONTAL SCALING SOLUTION-B
K875149 · Dentsply Intl. · Feb 1988
PERIODONTAL SCALING SOLUTION-C
K875150 · Dentsply Intl. · Feb 1988