Cleared Traditional

K982658 - KSEA ENDOSCOPES FOR DENTAL PROCEDURES

K982658 is an FDA 510(k) clearance for KSEA ENDOSCOPES FOR DENTAL PROCEDURES, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K982658 · KARL STORZ Endoscopy-America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
77d
Days
Class 1
Risk

K982658 is an FDA 510(k) clearance for the KSEA ENDOSCOPES FOR DENTAL PROCEDURES. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on October 15, 1998 after a review of 77 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 KARL STORZ Endoscopy-America, Inc. devices

FDA 510(k) Submission Details - K982658

510(k) Number K982658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1998
Decision Date October 15, 1998
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 127d · This submission: 77d
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 174
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K982658.
BIO-2000
K973765 · Micrylium Laboratories · Nov 1998
ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS
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BIOCLEAR CONCENTRATE
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ULTRACAM
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CLEAN SOURCE I, MODEL CS1000
K981144 · Aquarius Technologies, Inc. · Sep 1998
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K982480 · Dentalview, Inc. · Sep 1998