Cleared Traditional

K024148 - SALINUM

K024148 · Sinclair Pharmaceuticals, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
273d
Days
-
Risk

K024148 is an FDA 510(k) clearance for the SALINUM, ORCLAIR. Classified as Saliva, Artificial (product code LFD).

Submitted by Sinclair Pharmaceuticals, Ltd. (Godalming, Surrey, GB). The FDA issued a Cleared decision on September 15, 2003 after a review of 273 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 Sinclair Pharmaceuticals, Ltd. devices

FDA 510(k) Submission Details - K024148

510(k) Number K024148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2002
Decision Date September 15, 2003
Days to Decision 273 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
146d slower than avg
Panel avg: 127d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 18
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