Cleared Traditional

K863021 - CM-II, CM-I WATER UNIT

K863021 is an FDA 510(k) clearance for CM-II, manufactured by Sds Dental, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K863021 · Sds Dental, Inc. · Dental device
Download Printable Device Report (PDF)
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Oct 1986
Decision
54d
Days
Class 1
Risk

K863021 is an FDA 510(k) clearance for the CM-II, CM-I WATER UNIT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Sds Dental, Inc. (Washington, US). The FDA issued a Cleared decision on October 1, 1986 after a review of 54 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 Sds Dental, Inc. devices

FDA 510(k) Submission Details - K863021

510(k) Number K863021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1986
Decision Date October 01, 1986
Days to Decision 54 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 127d · This submission: 54d
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 178
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K863021.
A-DEC DECADE CUSPIDOR
K903455 · A-Dec, Inc. · Oct 1990
SUCTION ORA-SWAB(R) BRUSH KIT
K901806 · Sage Products, Inc. · Aug 1990
DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR.
K882526 · Aseptico, Inc. · Dec 1988
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