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FDA 510(k)

SUNTOUCH Dental Dressing

K-Number: K173196 · 2018-01-24

ApplicantHuizhou Foryou Medical Devices Co., Ltd.
Decision Date2018-01-24
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

SUNTOUCH Dental Dressing is a medical device manufactured by Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2018-01-24 under approval number K173196. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUNTOUCH Dental Dressing?

SUNTOUCH Dental Dressing is a medical device that received FDA 510(k) clearance on 2018-01-24. It is manufactured by Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K173196.

When was SUNTOUCH Dental Dressing approved by the FDA?

SUNTOUCH Dental Dressing received FDA 510(k) clearance on 2018-01-24, under approval number K173196.

What company makes SUNTOUCH Dental Dressing?

SUNTOUCH Dental Dressing is manufactured by Huizhou Foryou Medical Devices Co., Ltd..

What is the FDA product code for SUNTOUCH Dental Dressing?

The FDA product code for SUNTOUCH Dental Dressing is OLR.

Other Devices by Huizhou Foryou Medical Devices Co., Ltd.

K160022LUOFUCON Silicone Ag foam dressing K170077LUOFUCON Silicone Ag Foam Dressing with Border K172554LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing K201852Surgical Mask-Model Number: Ear Loop, Flat-Pleated K201016LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) K213598LUOFUCON Collagen Wound Dressing

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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