Cleared Traditional

K914697 - MDT/CASTLE PURUS DENTAL UNIT

K914697 is an FDA 510(k) clearance for MDT/CASTLE PURUS DENTAL UNIT, manufactured by Mdt Corp., Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K914697 · Mdt Corp., Inc. · Dental device
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Nov 1991
Decision
26d
Days
Class 1
Risk

K914697 is an FDA 510(k) clearance for the MDT/CASTLE PURUS DENTAL UNIT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Mdt Corp., Inc. (Rochester, US). The FDA issued a Cleared decision on November 13, 1991 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Mdt Corp., Inc. devices

FDA 510(k) Submission Details - K914697

510(k) Number K914697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1991
Decision Date November 13, 1991
Days to Decision 26 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
101d faster than avg
Panel avg: 127d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 66
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K914697.
A-DEC 2612 ASSISTANT'S CART
K933163 · A-Dec, Inc. · Oct 1993
A-DEC 3131 DUO WALLMOUNT (WITH INSTRUMENTATION)
K933165 · A-Dec, Inc. · Oct 1993
A-DEC 3127 ASSISTANT'S WALLMOUNT
K933168 · A-Dec, Inc. · Oct 1993
A-DEC PAC I PORTABLE UNIT
K903451 · A-Dec, Inc. · Oct 1990
A-DEC IC CONTROL HEAD
K903452 · A-Dec, Inc. · Oct 1990
A-DEC IC MICRO-CART
K903453 · A-Dec, Inc. · Oct 1990