Cleared Traditional

CAPHOSOL ARTIFICIAL SALIVA (K991938) - FDA 510(k) Clearance

K991938 · Inpharma A.S. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
62d
Days
-
Risk

K991938 is an FDA 510(k) clearance for the CAPHOSOL ARTIFICIAL SALIVA. Classified as Saliva, Artificial (product code LFD).

Submitted by Inpharma A.S. (Northborough, US). The FDA issued a Cleared decision on August 10, 1999 after a review of 62 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 Inpharma A.S. devices

Submission Details

510(k) Number K991938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1999
Decision Date August 10, 1999
Days to Decision 62 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 127d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 16
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K991938.
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TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
K171542 · Dr. Harold Katz, LLC (Dba Therabreath · Mar 2018