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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 the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2018-01-24 under 510(k) 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. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K173196.

When did SUNTOUCH Dental Dressing receive FDA 510(k) clearance?

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

Who is the listed applicant for SUNTOUCH Dental Dressing?

The FDA 510(k) record lists Huizhou Foryou Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNTOUCH Dental Dressing?

The FDA product code for SUNTOUCH Dental Dressing is OLR.

Other records listing Huizhou Foryou Medical Devices Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)K240809LUOFUCON® Silver Collagen DressingK242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)K240485LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)K232796LUOFUCON® Collagen Particles (Collagen Wound Dressing)K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing

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Related Devices (Code: OLR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLCK251908Emanate TrayEmanate BiomedicalK260126Curajel™ Oral GelUSpharma, Ltd.K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, LLC

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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