Cleared Traditional

CAPHOSOL (K030802) - FDA 510(k) Clearance

K030802 · Inpharma A.S. · Dental device
Download Printable Device Report (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.

View all Inpharma A.S. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 127d · This submission: 257d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 16
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