Cleared Traditional

K921999 - INTERJET(TM) GINGIVAL CARE INSTRUMENT

K921999 is an FDA 510(k) clearance for INTERJET(TM) GINGIVAL CARE INSTRUMENT, manufactured by Bausch & Lomb, Inc.. The device is a Class 1 Dental device with product code EFS cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K921999 · Bausch & Lomb, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
35d
Days
Class 1
Risk

K921999 is an FDA 510(k) clearance for the INTERJET(TM) GINGIVAL CARE INSTRUMENT. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by Bausch & Lomb, Inc. (Tucker, US). The FDA issued a Cleared decision on June 3, 1992 after a review of 35 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 - K921999

510(k) Number K921999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1992
Decision Date June 03, 1992
Days to Decision 35 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
93d faster than avg
Panel avg: 128d · This submission: 35d
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 35
Devices cleared under the same product code (EFS) and FDA review panel - the closest regulatory comparables to K921999.
WATER PIK PLUS PLAQUE CONTROL SYSTEM
K931380 · Teledyne Water Pik · Sep 1993
SHOWERFLOSS
K923457 · Summit Marketing Group, Inc. · Sep 1992
SHOWERFLOSS ORAL IRRIGATION UNIT
K922307 · Showerfloss, Inc. · Jun 1992
MAX-I-PROBE IRRIGATION SYSTEM
K913030 · Smith & Nephew, Inc. · Sep 1991
OXYFRESH OXYCARE 3000
K910832 · Oxyfresh · Apr 1991
PERIOGARD(R) PERIOPEN
K901955 · Colgate-Palmolive Co. · Apr 1991
K921999 · INTERJET(TM) GINGIVAL CARE INSTRUMENT
Download PDF FDA Summary Bausch & Lomb, Inc.