Cleared Traditional

K823180 - SA-21 DENTAL UNIT

K823180 is an FDA 510(k) clearance for SA-21 DENTAL UNIT, manufactured by Ritter Co.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K823180 · Ritter Co. · Dental device
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Nov 1982
Decision
21d
Days
Class 1
Risk

K823180 is an FDA 510(k) clearance for the SA-21 DENTAL UNIT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Ritter Co. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1982 after a review of 21 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 Ritter Co. devices

FDA 510(k) Submission Details - K823180

510(k) Number K823180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1982
Decision Date November 22, 1982
Days to Decision 21 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 127d · This submission: 21d
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 187
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K823180.
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