Cleared Traditional

K921071 - DENTOLOCK

K921071 is an FDA 510(k) clearance for DENTOLOCK, manufactured by Dentmed , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KOB cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K921071 · Dentmed , Ltd. · Gastroenterology & Urology device
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Mar 1992
Decision
20d
Days
Class 2
Risk

K921071 is an FDA 510(k) clearance for the DENTOLOCK. Classified as Catheter, Suprapubic (and Accessories) (product code KOB), Class II - Special Controls.

Submitted by Dentmed , Ltd. (Chicago, US). The FDA issued a Cleared decision on March 26, 1992 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5090 - the FDA gastroenterology and urology device 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 Dentmed , Ltd. devices

FDA 510(k) Submission Details - K921071

510(k) Number K921071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1992
Decision Date March 26, 1992
Days to Decision 20 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 131d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOB Device Classification - Class 2, Special Controls

Product Code KOB Catheter, Suprapubic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5090
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KOB Catheter, Suprapubic (and Accessories)

All 25
Devices cleared under the same product code (KOB) and FDA review panel - the closest regulatory comparables to K921071.
RUSCH SUPRAPUBIC TRAY
K970021 · Rusch, Inc. · Feb 1997
LINDNER/GOLOMB SP INTRODUCING SOUND
K953024 · Cook Urological, Inc. · Aug 1995
RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE
K952187 · Rusch, Inc. · Jul 1995
SUPRAPUBIC FLOW CONTROLLER
K904798 · Olympus Corp. · Nov 1991
MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER
K901603 · Bivona Medical Technologies · May 1990
SPEC 5* SUPRAPUBIC CATHETER
K881097 · Porges Corp. · Jun 1988