Cleared Traditional

K162167 - Caphosol Artifical Saliva Tablets

K162167 · Eusa Pharma (Uk) Limited · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
240d
Days
-
Risk

K162167 is an FDA 510(k) clearance for the Caphosol Artifical Saliva Tablets. Classified as Saliva, Artificial (product code LFD).

Submitted by Eusa Pharma (Uk) Limited (Hemel Hempstead, GB). The FDA issued a Cleared decision on March 31, 2017 after a review of 240 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 Eusa Pharma (Uk) Limited devices

FDA 510(k) Submission Details - K162167

510(k) Number K162167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2016
Decision Date March 31, 2017
Days to Decision 240 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
112d slower than avg
Panel avg: 128d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Consultant

Delphi Consulting Group
J. Harvey Knauss

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LFD Saliva, Artificial

All 45
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