Cleared Traditional

POINT, PAPER ENDODONTIC (K830814) - FDA 510(k) Clearance

K830814 · Endodent, Inc. · Dental device
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Apr 1983
Decision
22d
Days
-
Risk

K830814 is an FDA 510(k) clearance for the POINT, PAPER ENDODONTIC. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Endodent, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 6, 1983 after a review of 22 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 Endodent, Inc. devices

Submission Details

510(k) Number K830814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1983
Decision Date April 06, 1983
Days to Decision 22 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 127d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -