Cleared Traditional

K850988 - BOVO MOISTURE GUARD

K850988 is an FDA 510(k) clearance for BOVO MOISTURE GUARD, manufactured by E.H. Medical Co.. The device is a Class 1 Dental device with product code KHR cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K850988 · E.H. Medical Co. · Dental device
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Apr 1985
Decision
36d
Days
Class 1
Risk

K850988 is an FDA 510(k) clearance for the BOVO MOISTURE GUARD. Classified as Absorber, Saliva, Paper (product code KHR), Class I - General Controls.

Submitted by E.H. Medical Co. (San Diego, US). The FDA issued a Cleared decision on April 16, 1985 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6050 - 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 E.H. Medical Co. devices

FDA 510(k) Submission Details - K850988

510(k) Number K850988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1985
Decision Date April 16, 1985
Days to Decision 36 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 128d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

KHR Device Classification - Class 1, General Controls

Product Code KHR Absorber, Saliva, Paper
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6050
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.