Cleared Traditional

K873960 - LEWIS SAFE SLEEVE

K873960 is an FDA 510(k) clearance for LEWIS SAFE SLEEVE, manufactured by Cheri Lewis, D.D.S.. The device is a Class 1 Dental device with product code EIF cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K873960 · Cheri Lewis, D.D.S. · Dental device
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Dec 1987
Decision
67d
Days
Class 1
Risk

K873960 is an FDA 510(k) clearance for the LEWIS SAFE SLEEVE. Classified as Accessories, Retractor, Dental (product code EIF), Class I - General Controls.

Submitted by Cheri Lewis, D.D.S. (Beverly Hills, US). The FDA issued a Cleared decision on December 4, 1987 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Cheri Lewis, D.D.S. devices

FDA 510(k) Submission Details - K873960

510(k) Number K873960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1987
Decision Date December 04, 1987
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 128d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

EIF Device Classification - Class 1, General Controls

Product Code EIF Accessories, Retractor, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.