Cleared Traditional

K863500 - STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR

K863500 is an FDA 510(k) clearance for STAINLESS STEEL DEN. CROWN REMOVER & AM..., manufactured by Pacific Union Dental, Inc.. The device is a Class 1 Dental device with product code EIS cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K863500 · Pacific Union Dental, Inc. · Dental device
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Sep 1986
Decision
13d
Days
Class 1
Risk

K863500 is an FDA 510(k) clearance for the STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR. Classified as Remover, Crown (product code EIS), Class I - General Controls.

Submitted by Pacific Union Dental, Inc. (Silver Spring, US). The FDA issued a Cleared decision on September 22, 1986 after a review of 13 days - a notably fast clearance 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: 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 Pacific Union Dental, Inc. devices

FDA 510(k) Submission Details - K863500

510(k) Number K863500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1986
Decision Date September 22, 1986
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 128d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

EIS Device Classification - Class 1, General Controls

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.

Regulatory Peers - EIS Remover, Crown

All 15
Devices cleared under the same product code (EIS) and FDA review panel - the closest regulatory comparables to K863500.
ATD AUTOMATIC BRIDGE REMOVER
K992649 · J. Morita USA, Inc. · Oct 1999
SATIN CAST ECONOCAST
K833287 · Genesis Industries, Inc. · Jan 1984
C & B 40 PENTRO C & B40
K833290 · Genesis Industries, Inc. · Jan 1984
C & B 45
K833278 · Genesis Industries, Inc. · Dec 1983
C & B 61 PENTRON C & B61
K833289 · Genesis Industries, Inc. · Dec 1983
GOLD-PALLADIUM-SILVER BASED CAST/ALLOY
K833736 · Jeneric Ind. · Dec 1983