Cleared Traditional

K991938 - CAPHOSOL ARTIFICIAL SALIVA

K991938 · Inpharma A.S. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K991938

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 128d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 48
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K991938.
CAPHOSOL
K030802 · Inpharma A.S. · Nov 2003
SALINUM, ORCLAIR
K024148 · Sinclair Pharmaceuticals, Ltd. · Sep 2003
SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
K981693 · Gebauer Co. · Aug 2001
GLANDOSANE (SALIVART) SYNTHETIC SALIVA
K874106 · Fresenius USA, Inc. · Apr 1988
THROAT MOI-STIR
K840807 · Kingswood Laboratories, Inc. · May 1984
SALIVA SUBSTITUTE
K822971 · Roxane Laboratories, Inc. · Nov 1982
K991938 · CAPHOSOL ARTIFICIAL SALIVA
Download PDF FDA Summary Inpharma A.S.