Cleared Traditional

CLEANSER, ROOT CANAL (K802853) - FDA 510(k) Clearance

K802853 · Dentsply Intl. · Dental device
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Dec 1980
Decision
35d
Days
-
Risk

K802853 is an FDA 510(k) clearance for the CLEANSER, ROOT CANAL. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1980 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. 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 Dentsply Intl. devices

Submission Details

510(k) Number K802853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1980
Decision Date December 18, 1980
Days to Decision 35 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
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.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -