Cleared Traditional

K925967 - MEDCAM

K925967 is an FDA 510(k) clearance for MEDCAM, manufactured by Medcam USA, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K925967 · Medcam USA, Inc. · Dental device
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Aug 1993
Decision
272d
Days
Class 1
Risk

K925967 is an FDA 510(k) clearance for the MEDCAM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Medcam USA, Inc. (Boca Raton, US). The FDA issued a Cleared decision on August 24, 1993 after a review of 272 days - an extended review 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: 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 Medcam USA, Inc. devices

FDA 510(k) Submission Details - K925967

510(k) Number K925967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1992
Decision Date August 24, 1993
Days to Decision 272 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
145d slower than avg
Panel avg: 127d · This submission: 272d
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 189
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K925967.
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
MDT/CASTLE PURUS DENTAL UNIT
K914697 · Mdt Corp., Inc. · Nov 1991
ASEPTIMINI UNIT, ADU-10
K905401 · Aseptico, Inc. · Feb 1991
ORAL PHARYNGEAL CLEANSING DEVICE
K905011 · Concord/Portex · Jan 1991