Cleared Traditional

K110116 - XEROS DRY MOUTH PUMP

K110116 · Lorin Technologies Corporation · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
84d
Days
-
Risk

K110116 is an FDA 510(k) clearance for the XEROS DRY MOUTH PUMP. Classified as Saliva, Artificial (product code LFD).

Submitted by Lorin Technologies Corporation (Swansboro, US). The FDA issued a Cleared decision on April 8, 2011 after a review of 84 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 - K110116

510(k) Number K110116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2011
Decision Date April 08, 2011
Days to Decision 84 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
44d faster than avg
Panel avg: 128d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 46
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K110116.
AIR LIFT/XEROSTOM ARTIFICIAL SALIVA
K120552 · Biocosmetics Laboratories · Jun 2012
DRY MOUTH MOUTHWASH
K111250 · Dr. Fresh, Inc. · Apr 2012
BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
K103745 · Glaxosmithkline Consumer Healthcare (Gskch) · Jul 2011
GC ORAL MOISTURIZING GEL
K101346 · GC America, Inc. · Jan 2011
BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
K101477 · Glaxosmithkline Consumer Healthcare (Gskch) · Sep 2010
NEUTRASAL
K093642 · Invado Pharmaceuticals · Dec 2009
K110116 · XEROS DRY MOUTH PUMP
Download PDF FDA Summary Lorin Technologies Co…