Cleared Traditional

K951299 - EASY PNEUMATIC CROWN AND BRIDGE REMOVER

K951299 is an FDA 510(k) clearance for EASY PNEUMATIC CROWN AND BRIDGE REMOVER, manufactured by Dentco, Inc.. The device is a Class 1 Dental device with product code EIS cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K951299 · Dentco, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
160d
Days
Class 1
Risk

K951299 is an FDA 510(k) clearance for the EASY PNEUMATIC CROWN AND BRIDGE REMOVER. Classified as Remover, Crown (product code EIS), Class I - General Controls.

Submitted by Dentco, Inc. (White Plains, US). The FDA issued a Cleared decision on August 29, 1995 after a review of 160 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 Dentco, Inc. devices

FDA 510(k) Submission Details - K951299

510(k) Number K951299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1995
Decision Date August 29, 1995
Days to Decision 160 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 127d · This submission: 160d
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 K951299.
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