Who is the manufacturer of SUNTOUCH Dental Dressing?

Huizhou Foryou Medical Devices Co., Ltd. filed the 510(k) submission for SUNTOUCH Dental Dressing (K173196).

What is the FDA product code for SUNTOUCH Dental Dressing?

OLR. as a Class U device in the SU panel.

What is the regulatory pathway for SUNTOUCH Dental Dressing?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SUNTOUCH Dental Dressing?

Benacel® Dental Dressing (K090612).

Who can help prepare an FDA 510(k) submission like SUNTOUCH Dental Dressing?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SUNTOUCH Dental Dressing

K173196 · Huizhou Foryou Medical Devices Co., Ltd. · OLR · Jan 24, 2018 · SU

Device Facts

Record ID	K173196
Device Name	SUNTOUCH Dental Dressing
Applicant	Huizhou Foryou Medical Devices Co., Ltd.
Product Code	OLR · SU
Decision Date	Jan 24, 2018
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

SUNTOUCH® Dental Dressing is intended for use as a wound dressing in extraction sites, and may be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative and traumatic injuries.

Device Story

SUNTOUCH® Dental Dressing is a biocompatible, water-soluble regenerated cellulose textile; used as a wound dressing in oral extraction sites and surgical wounds. Upon contact with moist oral mucosa, the material dissolves and transforms into a gelatinous barrier; applied by clinician with gentle pressure to adhere to the wound site. The barrier protects the wound from irritation and pain; dissolves naturally within a few days; safe if swallowed. Excess material removable via sterile water or saline rinse. Intended for prescription use in clinical settings.

Clinical Evidence

No human clinical trials were conducted. Evidence includes bench testing (water absorbency, gelation time, pH, heavy metals, degree of polymerization per ASTM D1795, degree of etherification per ASTM D1439) and a porcine (minipig) model comparing local reaction and absorption time to the predicate. Biocompatibility testing (cytotoxicity, subcutaneous implantation, intracutaneous reactivity, systemic toxicity, pyrogenicity) performed per ISO 10993 standards showed no toxic effects.

Technological Characteristics

Material: Regenerated cellulose. Form: Knitted textile dressing. Mechanism: Water-soluble transformation into gelatinous barrier upon moisture contact. Sterilization: Radiation (SAL 10^-6). Standards: ASTM D1795 (polymerization), ASTM D1439 (etherification), USP <231> (heavy metals), USP <791> (pH).

Indications for Use

Indicated for use as a wound dressing in extraction sites and for temporary management of oral surgical wounds, including operative, postoperative, and traumatic injuries in patients requiring oral surgery.

Regulatory Classification

Identification

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Predicate Devices

Benacel® Dental Dressing (K090612)

Related Devices

K090612 — BENACEL · Unicare Biomedical · Jul 24, 2009
K211851 — Ora-Aid · Tbm Corporation · Jan 11, 2022
K221428 — PerioStom Dental Dressing · Forward Science, LLC · Dec 22, 2022
K152600 — Collagen Dental Wound Dressings · Collagen Matrix, Inc. · Jun 23, 2016
K230529 — HealiAid Dental Collagen Wound Dressing · Maxigen Biotech, Inc. · Nov 22, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Huizhou Foryou Medical Devices Co., Ltd. Junfeng Zhang Development Engineer North Shangxia Rd., Dongjiang Hi-tech Industry Park Huizhou, 516005 Cn January 24, 2018 Re: K173196 Trade/Device Name: SUNTOUCH Dental Dressing Regulatory Class: Unclassified Product Code: MGO Dated: September 29, 2017 Received: October 2, 2017 Dear Junfeng Zhang: We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Mary S. Runner -S For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K173196 Device Name SUNTOUCH® Dental Dressing #### Indications for Use (Describe) SUNTOUCH® Dental Dressing is intended for use as a wound dressing in extraction sites, and may be used as a wound dressing for the temporary management of oral surgical wounds, such as operative and traumatic injuries. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| > Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ # 510(k) Summary ## 510(K) Number (if known): K173196 #### 1. Submitter Identification: Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd., Dongjiang Hi-tech Industry Park, 516005, Huizhou, P. R. China. Establishment Registration Number: 3007735241 Contact Person: Junfeng Zhang Position: Development Engineer Tel: +86-0752-5302186 Fax: +86-0752-5302020 Email: jfzhang@foryougroup.com Summary day: 01/24/2018 ### 2. Subject Device Identification: Type of 510(k) submission: Traditional Trade Name: SUNTOUCH® Dental Dressing Common Name: Dental Dressing Classification Name: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Product Code: MGQ Regulation Number: Unclassified Review Panel: General & Plastic Surgery # 3. Primary Predicate Device Identification 510(k) Number: K090612 Product Name: Benacel® Dental Dressing {4}------------------------------------------------ Manufacturer: Unicare Biomedical, Inc. #### 4. Device Description SUNTOUCH® Dental Dressing is made from biocompatible regenerated cellulose, chemically treated to become water-soluble, contains no chemical additives. Upon contact with moist oral wound, the material dissolves and transforms into a gelatinous material. By applying gentle pressure at this time, the material will adhere to the wound and form a barrier, protecting the wound from further irritation. SUNTOUCH® Dental Dressing dissolves in a few days and is safe if swallowed. Excess dressing material may be removed by rinsing with sterile water or saline solution. The dressings are sterilized with Sterility Assurance Level (SAL) of 10-6. #### 5. Intended Use Statement SUNTOUCH® Dental Dressing is intended for use as a wound dressing in extraction sites, and may be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative and traumatic injuries. ### 6. Comparison to Predicate Device SUNTOUCH® Dental Dressing is compared with the following Predicate Device in terms of intended use, design, material, size, structure, performance test, biocompatibility test and animal test. 510(k) Number: K090612 Product Name: Benacel® Dental Dressing Manufacturer: Unicare Biomedical, Inc The following table (Table 5.1) shows similarities and differences of technology characteristics between proposed device and predicate device. {5}------------------------------------------------ | Item | Proposed Device | Predicate Device (K090612) | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | SUNTOUCH® Dental Dressing is intended for use as a wound dressing in extraction sites, and may be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative and traumatic injuries. | Benacel® Dental Dressing is intended for use as a wound dressing in extraction sites and the management of alveolar osteitis (dry socket) and may be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites, and traumatic injuries. Benacel® Dental Dressing may also be used as a wound dressing for the management and protection of oral lesions, including sores, ulcers, and injuries, such as cuts, lacerations and abrasions of the oral mucosa. | | Prescription/ OTC | Prescription | Prescription | | Mechanism | When contact with moist oral mucosa, the material dissolves and transforms into a gelatinous material. By applying gentle pressure at this time, the material will adhere to the wound and form a barrier, protecting the wound from further irritation and pain. | When contact with moist oral mucosa, the material dissolves and transforms into a gelatinous material. By applying gentle pressure at this time, the material will adhere to the wound and form a barrier, protecting the wound from further irritation and pain. | | Material | Regenerated cellulose | Regenerated cellulose | | Size | $5mm×7mm$ (plug), $6mm×8mm$ (plug), $11mm×11mm$ (pack), $15mm×15mm$ (pack), $19mm×19mm$ (pack), $30mm×30mm$ (sheet) | $5mm × 7mm$ (plug), $6mm×8mm$ (plug), $15mm × 15mm$ (sheet), $50mm × 50mm$ (sheet) | | Structure | Textile | textile | | Fabric Type | Knitted Fabric | Woven Fabric | | Single Use | Yes | Yes | | Sterilization | Radiation | Radiation | # Table 5.1 Comparison of Technology Characteristics of Proposed and Predicate Device {6}------------------------------------------------ The indication for use of proposed device is included in that of predicate device, therefore, this difference is considered not to affect the Substantially Equivalency (SE) between the proposed and predicate device. The proposed device has more size specifications than that of predicate device. The size will not affect the function and performance of the product. And more size will give user more choice per wound area. Therefore, this difference is considered not to affect the Substantially Equivalency (SE) between the proposed and predicate device. The fabric type of the proposed is knitted fabric, and the fabric type of the predicate device is woven fabric. But the different of fabric type do not affect the safe and effective performance. SUNTOUCH® Dental Dressing and its predicate device are both made from regenerated cellulose, and utilize the same mechanism. They are both indicated for protecting the oral wound. We recorded the infrared spectra of SUNTOUCH® Dental Dressing and Benacel® Dental Dressing. The almost identical spectra indicated both devices are very similar in chemical structure. The performance tests between proposed device and predicate device were conducted to evaluate the properties of the proposed and predicate device. The following parameters were monitored: Water absorbency, Gelation time, Weight per unit area, Content of sodium (USP Carboxymethylcellulose Sodium), Degree of polymerization (ASTM D 1795), Heavy metals (USP <231>), Chloride, pH value (USP <791>), Degree of etherification (ASTM D {7}------------------------------------------------ 1439) and Adhesion force. The results showed that the proposed and predicate device were substantially equivalent. SUNTOUCH® Dental Dressing was evaluated in a porcine (minipig) model to evaluate the local reaction and absorption time as compared to predicate device. The results showed that the proposed and predicate device were substantially equivalent. The biocompatibility testing was conducted to confirm the safe performance of SUNTOUCH® Dental Dressing. The biocompatibility tests (Table 5.2) were conducted following procedures outlined in the respective consensus standards, and the results met all relevant requirements in the test standards. | Description | | proposed device | |-----------------------------------------------|--|----------------------------------| | Ames | | | | In vitro Mammalian Chromosome Aberration | | No Toxic Effect (ISO 10993-3) | | In Vivo Mammalian Erythrocyte Micronucleus | | | | Cytotoxicity | | No Toxic Effect (ISO10993-5) | | Subcutaneous implantation | | No Effect (ISO 10993-6) | | Skin Sensitization | | | | Intracutaneous Reactivity | | No Effect (ISO 10993-10) | | Oral Mucosa Irritation | | | | Acute Systematic Toxicity | | No Effect (ISO 10993-11) | | Pyrogenicity | | No Effect (ISO 10993-11) | | Subacute Systematic Toxicity | | No Effect (ISO 10993-11) | Table 5.2 Biocompatibility Test #### 7. Substantial Equivalent Statement Based on the comparisons of intended use, design, materials, size, structure, performance test, animal test and biocompatibility test. {8}------------------------------------------------ SUNTOUCH® Dental Dressing is substantial equivalent to its predicate device.