Cleared Traditional

K983739 - OPTUM, INTRAORAL CAMERA SYSTEM

K983739 is an FDA 510(k) clearance for OPTUM, manufactured by Camsight, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K983739 · Camsight, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
89d
Days
Class 1
Risk

K983739 is an FDA 510(k) clearance for the OPTUM, INTRAORAL CAMERA SYSTEM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Camsight, Inc. (Los Angeles, US). The FDA issued a Cleared decision on January 19, 1999 after a review of 89 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 Camsight, Inc. devices

FDA 510(k) Submission Details - K983739

510(k) Number K983739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1998
Decision Date January 19, 1999
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
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 152
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K983739.
SCICAN CLASSIC
K984556 · Scholly Fiberoptic GmbH · Feb 1999
ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III
K984609 · Lite Specialty Metal Works, Inc. · Feb 1999
PLANMECA INTRACAM STATION
K984013 · Planmeca Oy · Jan 1999
BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES
K983661 · Belmont Equipment Corp. · Jan 1999
S555 INTRAORAL DENTAL CAMERA
K983625 · Sopro · Jan 1999
PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE
K983735 · Pall Medical · Jan 1999