Cleared Traditional

K854642 - SOLAR CART

K854642 is an FDA 510(k) clearance for SOLAR CART, manufactured by Alpine Dental Equipment Co.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K854642 · Alpine Dental Equipment Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
115d
Days
Class 1
Risk

K854642 is an FDA 510(k) clearance for the SOLAR CART. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Alpine Dental Equipment Co. (East Orange, US). The FDA issued a Cleared decision on March 14, 1986 after a review of 115 days - within the typical 510(k) review window.

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

View all Alpine Dental Equipment Co. devices

FDA 510(k) Submission Details - K854642

510(k) Number K854642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1985
Decision Date March 14, 1986
Days to Decision 115 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 128d · This submission: 115d
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 193
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K854642.
CM-II, CM-I WATER UNIT
K863021 · Sds Dental, Inc. · Oct 1986
EUROCART SR-4, EUROCART M-IV, ISOCART III
K863010 · Sds Dental, Inc. · Sep 1986
CABINET II AUXILIARY UNIT
K863023 · Sds Dental, Inc. · Sep 1986
SPACELINE DENTAL CHAIR-UNIT
K801685 · Pacific Dental Corp. · Aug 1980
MOBILE UNITS, I,II,III,IV
K790112 · Dentsply Intl. · Feb 1979