Cleared Traditional

CURING LIGHT (K843049) - FDA 510(k) Clearance

K843049 · Penn-Med Technology, Inc. · Dental device
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Apr 1985
Decision
252d
Days
-
Risk

K843049 is an FDA 510(k) clearance for the CURING LIGHT.

Submitted by Penn-Med Technology, Inc. (West Conshohocken, US). The FDA issued a Cleared decision on April 12, 1985 after a review of 252 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Penn-Med Technology, Inc. devices

Submission Details

510(k) Number K843049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1984
Decision Date April 12, 1985
Days to Decision 252 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 127d · This submission: 252d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -