Cleared Traditional

K980474 - TELICAM

K980474 is an FDA 510(k) clearance for TELICAM, manufactured by Dental/Medical Diagnostic Systems, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K980474 · Dental/Medical Diagnostic Systems, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
66d
Days
Class 1
Risk

K980474 is an FDA 510(k) clearance for the TELICAM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Dental/Medical Diagnostic Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on April 13, 1998 after a review of 66 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 Dental/Medical Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K980474

510(k) Number K980474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1998
Decision Date April 13, 1998
Days to Decision 66 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
61d faster than avg
Panel avg: 127d · This submission: 66d
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 123
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K980474.
VIPERCAM
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ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE
K982009 · Scitech Solutions, Inc. · Jun 1998
PRINCESS SYRINGE
K980577 · Sodexco · May 1998
SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020
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TRUE VISION, TRUE VISION II
K974542 · Medical Dynamics, Inc. · Feb 1998
CLEARLINE PLUS, DENTAL WATERLINE FILTER
K973996 · Scitech Solutions, Inc. · Feb 1998