Cleared Traditional

K802685 - REOLIT

K802685 is the FDA 510(k) clearance for REOLIT by Vivadent (Usa), Inc.. It is a Class 2 Dental device (product code EJK) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K802685 · Vivadent (Usa), Inc. · Dental device
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Nov 1980
Decision
15d
Days
Class 2
Risk

K802685 is an FDA 510(k) clearance for the REOLIT. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Vivadent (Usa), Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3250 - 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 Vivadent (Usa), Inc. devices

Submission Details

510(k) Number K802685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1980
Decision Date November 12, 1980
Days to Decision 15 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 127d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJK Liner, Cavity, Calcium Hydroxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3250
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 Dental devices follow this clearance model.

Regulatory Peers - EJK Liner, Cavity, Calcium Hydroxide

All 48
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K802685.
KERR CAVALITE
K872147 · Kerr Corporation (Danbury) · Aug 1987
KERR SEALAPEX ROOT CANAL SEALER
K841910 · Sybron Corp. · Jul 1984
IMPROVED DYCAL
K820215 · Dentsply Intl. · Mar 1982
MONOJECT PULP-CAPPING MATERIAL
K791088 · Sherwood Medical Co. · Oct 1979
LINER, CAVITY CALCIUM HYDROXIDE
K781688 · Kerr Corporation (Danbury) · Dec 1978