Cleared Traditional

TELEDYNE DENSCO DRY TIPS SALIVA ABSORB- (K843539) - FDA 510(k) Clearance

Class I Dental device.

K843539 · Molnlycke A/S Hospital Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
258d
Days
Class 1
Risk

K843539 is an FDA 510(k) clearance for the TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-. Classified as Cotton, Roll (product code EFN), Class I - General Controls.

Submitted by Molnlycke A/S Hospital Products (Walker, US). The FDA issued a Cleared decision on May 23, 1985 after a review of 258 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6050 - 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: 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 Molnlycke A/S Hospital Products devices

Submission Details

510(k) Number K843539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1984
Decision Date May 23, 1985
Days to Decision 258 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 127d · This submission: 258d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFN Cotton, Roll
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6050
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.