Cleared Traditional

K030802 - CAPHOSOL

K030802 · Inpharma A.S. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
257d
Days
-
Risk

K030802 is an FDA 510(k) clearance for the CAPHOSOL. Classified as Saliva, Artificial (product code LFD).

Submitted by Inpharma A.S. (Northborough, US). The FDA issued a Cleared decision on November 25, 2003 after a review of 257 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K030802

510(k) Number K030802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2003
Decision Date November 25, 2003
Days to Decision 257 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
129d slower than avg
Panel avg: 128d · This submission: 257d
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 K030802.
ORAL BALANCE LIQUID/ GEL
K061331 · Laclede, Inc. · Jul 2006
TGO SPRAY
K051812 · Laboratoires Carilene S.A.S. · Oct 2005
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
K041563 · Glaxosmithkline Consumer Healthcare, L.P. · Aug 2004
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
CAPHOSOL ARTIFICIAL SALIVA
K991938 · Inpharma A.S. · Aug 1999
K030802 · CAPHOSOL
Download PDF FDA Summary Inpharma A.S.