Cleared Traditional

K973410 - ULTRACAM

K973410 is an FDA 510(k) clearance for ULTRACAM, manufactured by W. Edward Johansen. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 394-day FDA review.

K973410 · W. Edward Johansen · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
394d
Days
Class 1
Risk

K973410 is an FDA 510(k) clearance for the ULTRACAM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by W. Edward Johansen (Los Angeles, US). The FDA issued a Cleared decision on October 8, 1998 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K973410

510(k) Number K973410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1997
Decision Date October 08, 1998
Days to Decision 394 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
266d slower than avg
Panel avg: 128d · This submission: 394d
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 255
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K973410.
ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS
K983285 · Engle Dental Systems · Nov 1998
BIOCLEAR CONCENTRATE
K981565 · Waggoner Product Development · Oct 1998
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998
CLEAN SOURCE I, MODEL CS1000
K981144 · Aquarius Technologies, Inc. · Sep 1998
PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH.
K982480 · Dentalview, Inc. · Sep 1998
FLUID CONTROL
K982117 · T.A. Coleman Ent. · Sep 1998
K973410 · ULTRACAM
Download PDF W. Edward Johansen