Cleared Traditional

K822971 - SALIVA SUBSTITUTE

K822971 · Roxane Laboratories, Inc. · Dental device
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Nov 1982
Decision
39d
Days
-
Risk

K822971 is an FDA 510(k) clearance for the SALIVA SUBSTITUTE. Classified as Saliva, Artificial (product code LFD).

Submitted by Roxane Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1982 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. 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 Roxane Laboratories, Inc. devices

FDA 510(k) Submission Details - K822971

510(k) Number K822971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1982
Decision Date November 16, 1982
Days to Decision 39 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 128d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -