Cleared Traditional

K863019 - F-11 REFLECTOR / F-II STANDARD REFLECTOR

K863019 is an FDA 510(k) clearance for F-11 REFLECTOR / F-II STANDARD REFLECTOR, manufactured by Sds Dental, Inc.. The device is a Class 1 Dental device with product code EAZ cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K863019 · Sds Dental, Inc. · Dental device
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Sep 1986
Decision
52d
Days
Class 1
Risk

K863019 is an FDA 510(k) clearance for the F-11 REFLECTOR / F-II STANDARD REFLECTOR. Classified as Light, Operating, Dental (product code EAZ), Class I - General Controls.

Submitted by Sds Dental, Inc. (Washington, US). The FDA issued a Cleared decision on September 29, 1986 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4630 - 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.

FDA 510(k) Submission Details - K863019

510(k) Number K863019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1986
Decision Date September 29, 1986
Days to Decision 52 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
76d faster than avg
Panel avg: 128d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

EAZ Device Classification - Class 1, General Controls

Product Code EAZ Light, Operating, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4630
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 - EAZ Light, Operating, Dental

All 22
Devices cleared under the same product code (EAZ) and FDA review panel - the closest regulatory comparables to K863019.
DENTAL EQUIPMENT PROTECTION DEVICES
K891216 · Pro-Safe Professional Linens, Inc. · Jun 1989
DENTAL LAMP HANDLE COVER
K884223 · Steri-Shield Products, Inc. · Mar 1989
THE WOOG ORATEST
K874374 · Woog Intl. · Jan 1988
OPTI-BEAM IV
K832919 · Dentsply Intl. · Mar 1984
LUNA-VUE DENTAL OPERATING LIGHT
K801683 · Pacific Dental Corp. · Aug 1980
KLIP-LITE
K790984 · Innovators, Inc. · Oct 1979
K863019 · F-11 REFLECTOR / F-II STANDARD REFLECTOR
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