Cleared Traditional

K021524 - LIGHT CURE DENTAL DAM

K021524 is an FDA 510(k) clearance for LIGHT CURE DENTAL DAM, manufactured by Prime Dental Manufacturing, Inc.. The device is a Class 1 Dental device with product code EIE cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K021524 · Prime Dental Manufacturing, Inc. · Dental device
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Jul 2002
Decision
70d
Days
Class 1
Risk

K021524 is an FDA 510(k) clearance for the LIGHT CURE DENTAL DAM. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Prime Dental Manufacturing, Inc. (Chicago, US). The FDA issued a Cleared decision on July 19, 2002 after a review of 70 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K021524

510(k) Number K021524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2002
Decision Date July 19, 2002
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 128d · This submission: 70d
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 22
Devices cleared under the same product code (EIE) and FDA review panel - the closest regulatory comparables to K021524.
GC TION GINGIVAL PROTECTOR
K043301 · GC America, Inc. · Jan 2005
BRITESMILE MASKING CREAM
K040797 · Britesmile, Inc. · Apr 2004
PULPDENT PUTTY DAM
K022522 · Pulpdent Corporation · Sep 2002
NIVEOUS LIQUID DAM
K021613 · Shofu Dental Corp. · Jun 2002
BRITESMILE BARRIER MATERIAL
K010935 · Britesmile, Inc. · Sep 2001
POWER BLOCK
K983227 · Kreativ, Inc. · Dec 1998
K021524 · LIGHT CURE DENTAL DAM
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