Cleared Traditional

OMS CRYO (K844467) - FDA 510(k) Clearance

K844467 · Optical Micro Systems, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 127d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -