Cleared Traditional

K984641 - FLEXISCOPE OPTOMODUL

K984641 is an FDA 510(k) clearance for FLEXISCOPE OPTOMODUL, manufactured by Schoelly Fiberoptic GmbH. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K984641 · Schoelly Fiberoptic GmbH · Dental device
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Mar 1999
Decision
88d
Days
Class 1
Risk

K984641 is an FDA 510(k) clearance for the FLEXISCOPE OPTOMODUL. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Schoelly Fiberoptic GmbH (Newton, US). The FDA issued a Cleared decision on March 29, 1999 after a review of 88 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 Schoelly Fiberoptic GmbH devices

FDA 510(k) Submission Details - K984641

510(k) Number K984641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1998
Decision Date March 29, 1999
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 128d · This submission: 88d
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 205
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