Cleared Traditional

SUNTOUCH Dental Dressing (K173196) - FDA 510(k) Clearance

K173196 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
114d
Days
-
Risk

K173196 is an FDA 510(k) clearance for the SUNTOUCH Dental Dressing. Classified as Oral Wound Dressing (product code OLR).

Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on January 24, 2018 after a review of 114 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.

View all Huizhou Foryou Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K173196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2017
Decision Date January 24, 2018
Days to Decision 114 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 115d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.