Cleared Traditional

K872301 - DENTOCULT-SM CULTURE-PADDLE

K872301 is an FDA 510(k) clearance for DENTOCULT-SM CULTURE-PADDLE, manufactured by Orion Corp.. The device is a Class 1 Microbiology device with product code JSI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K872301 · Orion Corp. · Microbiology device
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Sep 1987
Decision
88d
Days
Class 1
Risk

K872301 is an FDA 510(k) clearance for the DENTOCULT-SM CULTURE-PADDLE. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on September 11, 1987 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - the FDA microbiology device 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 Orion Corp. devices

FDA 510(k) Submission Details - K872301

510(k) Number K872301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1987
Decision Date September 11, 1987
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 102d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

JSI Device Classification - Class 1, General Controls

Product Code JSI Culture Media, Selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSI Culture Media, Selective And Differential

All 231
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