Cleared Traditional

K063148 - SOCK IT! ORAL PAIN GEL

K063148 · Merlin Group Dba Mcmerlin Dental Company · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
93d
Days
-
Risk

K063148 is an FDA 510(k) clearance for the SOCK IT! ORAL PAIN GEL. Classified as Oral Wound Dressing (product code OLR).

Submitted by Merlin Group Dba Mcmerlin Dental Company (Grand Prairie, US). The FDA issued a Cleared decision on January 17, 2007 after a review of 93 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K063148

510(k) Number K063148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2006
Decision Date January 17, 2007
Days to Decision 93 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

OLR Device Classification - Class 0,

Product Code OLR Oral Wound Dressing
Device Class -
Definition Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq.

Regulatory Peers - OLR Oral Wound Dressing

All 42
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K063148.
CARAPASTE ORAL WOUND DRESSING
K082856 · Mcgrath Pharmaceuticals, Inc. · Oct 2008
ULCELOOCIN ORAL ULCER PATCH
K070842 · Sunshine International Group, Inc. · Jun 2007
GENGIGEL MOUTHRINSE
K053342 · Ricerfarma Srl · Mar 2007
MUGARD MUCOADHESIVE ORAL WOUND RINSE
K062795 · Access Pharmaceuticals, Inc. · Dec 2006
HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12
K060363 · Hemcon, Inc. · Jul 2006
ORAMAGIC PLUS ORAL WOUND RINSE
K060340 · Mpm Medical., Inc. · May 2006
K063148 · SOCK IT! ORAL PAIN GEL
Download PDF FDA Summary Merlin Group Dba Mcme…