Cleared Traditional

HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER (K854795) - FDA 510(k) Clearance

Class I Dental device.

K854795 · Fran Hazelton Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
92d
Days
Class 1
Risk

K854795 is an FDA 510(k) clearance for the HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER. Classified as Remover, Crown (product code EIS), Class I - General Controls.

Submitted by Fran Hazelton Co. (Orland, US). The FDA issued a Cleared decision on March 4, 1986 after a review of 92 days - within the typical 510(k) review window.

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 Fran Hazelton Co. devices

Submission Details

510(k) Number K854795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1985
Decision Date March 04, 1986
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 127d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIS Remover, Crown
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.