Cleared Traditional

K982009 - ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE

K982009 is an FDA 510(k) clearance for ONE WEEK BACKSTOP DENTAL ANTI-RETRACTIO..., manufactured by Scitech Solutions, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K982009 · Scitech Solutions, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
84d
Days
Class 1
Risk

K982009 is an FDA 510(k) clearance for the ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Scitech Solutions, Inc. (Seatttle, US). The FDA issued a Cleared decision on June 25, 1998 after a review of 84 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 Scitech Solutions, Inc. devices

FDA 510(k) Submission Details - K982009

510(k) Number K982009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1998
Decision Date June 25, 1998
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
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 K982009.
DIGITAL DOC
K981663 · Digital Doc, LLC · Aug 1998
THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES
K980106 · Proma, Inc. · Aug 1998
VIPERCAM
K981534 · Integra Medical · Jul 1998
PRINCESS SYRINGE
K980577 · Sodexco · May 1998
TELICAM
K980474 · Dental/Medical Diagnostic Systems, Inc. · Apr 1998
SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020
K974487 · Asi Medical, Inc. · Feb 1998