Cleared Traditional

K960506 - A-DEC PERFORMER CONTROL UNIT

K960506 is an FDA 510(k) clearance for A-DEC PERFORMER CONTROL UNIT, manufactured by A-Dec, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K960506 · A-Dec, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
49d
Days
Class 1
Risk

K960506 is an FDA 510(k) clearance for the A-DEC PERFORMER CONTROL UNIT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on March 25, 1996 after a review of 49 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 A-Dec, Inc. devices

FDA 510(k) Submission Details - K960506

510(k) Number K960506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1996
Decision Date March 25, 1996
Days to Decision 49 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
78d faster than avg
Panel avg: 127d · This submission: 49d
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 171
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K960506.
PORTA'PURE/DENTAL
K961409 · Water Solution Technologies · Jun 1996
BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE
K960556 · Scitech Solutions, Inc. · May 1996
POWERS ANTI-BACTERIAL VALVE
K954471 · Powers Dental & Medical Technology, Inc. · Apr 1996
STOMAVISION (STV)
K951074 · Trophy Radiologie · Sep 1995
INTRAORAL VIDEO SCOPE AND WINDOW TUBE
K951019 · Cuda Products Co. · May 1995
VACSTAR
K942698 · Air Techniques, Inc. · Mar 1995