Cleared Traditional

PULPDENT POLYAMIDE DENTIN LINER (K911285) - FDA 510(k) Clearance

Class I Dental device.

K911285 · Pulpdent Corp. · Dental device
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Oct 1991
Decision
204d
Days
Class 1
Risk

K911285 is an FDA 510(k) clearance for the PULPDENT POLYAMIDE DENTIN LINER. Classified as Punch, Biopsy, Surgical (product code EME), Class I - General Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on October 9, 1991 after a review of 204 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Pulpdent Corp. devices

Submission Details

510(k) Number K911285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1991
Decision Date October 09, 1991
Days to Decision 204 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 127d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EME Punch, Biopsy, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.