Cleared Traditional

K844467 - OMS CRYO

K844467 · Optical Micro Systems, Inc. · Dental device
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Feb 1985
Decision
95d
Days
-
Risk

K844467 is an FDA 510(k) clearance for the OMS CRYO.

Submitted by Optical Micro Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on February 22, 1985 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. 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 Optical Micro Systems, Inc. devices

FDA 510(k) Submission Details - K844467

510(k) Number K844467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1984
Decision Date February 22, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 127d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -