Cleared Traditional

K021613 - NIVEOUS LIQUID DAM

K021613 is an FDA 510(k) clearance for NIVEOUS LIQUID DAM, manufactured by Shofu Dental Corp.. The device is a Class 1 Dental device with product code EIE cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K021613 · Shofu Dental Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
35d
Days
Class 1
Risk

K021613 is an FDA 510(k) clearance for the NIVEOUS LIQUID DAM. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Shofu Dental Corp. (San Marcos, US). The FDA issued a Cleared decision on June 20, 2002 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6300 - 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 Shofu Dental Corp. devices

FDA 510(k) Submission Details - K021613

510(k) Number K021613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2002
Decision Date June 20, 2002
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
92d faster than avg
Panel avg: 127d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

EIE Device Classification - Class 1, General Controls

Product Code EIE Dam, Rubber
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6300
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 - EIE Dam, Rubber

All 11
Devices cleared under the same product code (EIE) and FDA review panel - the closest regulatory comparables to K021613.
armor LC
K182118 · Mavrik Dental Systems, Ltd. · May 2019
GC TION GINGIVAL PROTECTOR
K043301 · GC America, Inc. · Jan 2005
PULPDENT PUTTY DAM
K022522 · Pulpdent Corporation · Sep 2002
POWER BLOCK
K983227 · Kreativ, Inc. · Dec 1998
FASTDAM
K972775 · Interdent, Inc. · Feb 1998
DENTAL DAM SILICONE
K961472 · Worldwide Dental, Inc. · Aug 1996