PerioStom Dental Dressing

K221428 · Forward Science, LLC · OLR · Dec 22, 2022 · SU

Device Facts

• Record ID: K221428
• Device Name: PerioStom Dental Dressing
• Applicant: Forward Science, LLC
• Product Code: OLR · SU
• Decision Date: Dec 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

PerioStom™ Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. PerioStom™ Dental Dressing can be utilized for the pain relief and protection of oral mucosa due to irritation, trauma, or following iatrogenic procedures such as scaling and root planing.

Device Story

PerioStom™ Dental Dressing is a powder-based wound dressing composed of spray-dried chitosan; supplied in stainless steel containers or preloaded cartridges for use with the FS Dispenser™. Intended for use by dental professionals in a clinical setting. Applied to oral mucosal tissue via dental instruments (e.g., periosteal elevators) or dry gloved fingers. Upon contact with saliva, blood, or crevicular fluids, the powder transforms into a bioadherent gel. This gel forms a physical barrier over compromised mucosa, protecting the site from contamination and irritation while providing pain relief. The device is for single-use application per wound.

Clinical Evidence

No clinical performance testing was conducted. Substantial equivalence is supported by bench testing (viscosity, pH, microbial, wound barrier) and ISO 10993 biocompatibility testing (cytotoxicity, sensitization, irritation/intracutaneous reactivity).

Technological Characteristics

Material: spray-dried chitosan. Form factor: powder-based dressing in stainless steel containers or preloaded cartridges. Application: manual via dental instrument or FS Dispenser™. Mechanism: bioadherent gel formation upon contact with oral fluids. Biocompatibility: meets ISO 10993 standards.

Indications for Use

Indicated for use by dental professionals as an oral wound dressing to provide a physical barrier for temporary protection of oral mucosal tissue and pain relief for patients experiencing oral mucosal irritation, trauma, or post-iatrogenic procedures (e.g., scaling and root planing).

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

• HemCon® Dental Bandage (K060363)

Submission Summary (Full Text)

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December 22, 2022

Forward Science LLC Brian Pikkula Chief Scientific Officer 10810 Criaghead Dr Houston, Texas 77025

Re: K221428

Trade/Device Name: PerioStom Dental Dressing Regulatory Class: Unclassified Product Code: OLR, MGQ Dated: November 22, 2022 Received: November 23, 2022

Dear Brian Pikkula:

We have reviewed your 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K221428

Device Name PerioStom™ Dental Dressing

#### Indications for Use (Describe)

PerioStom™ Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial, sans-serif;"> <div> <table border="0" cellpadding="0" cellspacing="0"><tbody><tr><td><div> <table border="1" cellpadding="0" cellspacing="0"><tbody><tr><td style="padding: 0px;" valign="middle" width="18"><div align="center"> <span> <b>X</b> </span> </div></td></tr></tbody></table> </div></td><td valign="middle"><span>Prescription Use (Part 21 CFR 801 Subpart D)</span></td></tr></tbody></table> </div> </span> | <div> <table border="1" cellpadding="0" cellspacing="0"><tbody><tr><td style="padding: 0px;" valign="middle" width="18"><div align="center"> <span> <b>X</b> </span> </div></td></tr></tbody></table> </div> | <div align="center"> <span> <b>X</b> </span> </div> | <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| <div> <table border="1" cellpadding="0" cellspacing="0"><tbody><tr><td style="padding: 0px;" valign="middle" width="18"><div align="center"> <span> <b>X</b> </span> </div></td></tr></tbody></table> </div> | <div align="center"> <span> <b>X</b> </span> </div> | <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> | |
| <div align="center"> <span> <b>X</b> </span> </div> | | | |
| <span style="font-family: Arial, sans-serif;"> <div> <table border="0" cellpadding="0" cellspacing="0"><tbody><tr><td><div> <table border="1" cellpadding="0" cellspacing="0"><tbody><tr><td style="padding: 0px;" valign="middle" width="18"><div align="center"> <span> </span> </div></td></tr></tbody></table> </div></td><td valign="middle"><span>Over-The-Counter Use (21 CFR 801 Subpart D)</span></td></tr></tbody></table> </div> </span> | <div> <table border="1" cellpadding="0" cellspacing="0"><tbody><tr><td style="padding: 0px;" valign="middle" width="18"><div align="center"> <span> </span> </div></td></tr></tbody></table> </div> | <div align="center"> <span> </span> </div> | <span>Over-The-Counter Use (21 CFR 801 Subpart D)</span> |
| <div> <table border="1" cellpadding="0" cellspacing="0"><tbody><tr><td style="padding: 0px;" valign="middle" width="18"><div align="center"> <span> </span> </div></td></tr></tbody></table> </div> | <div align="center"> <span> </span> </div> | <span>Over-The-Counter Use (21 CFR 801 Subpart D)</span> | |
| <div align="center"> <span> </span> </div> | | | |

|_ | Over-The-Counter Use (21 CFR 801 Subpart C)

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### Forward Science LLC

#### 510(k) SUMMARY

| Submitted by: | Forward Science LLC<br>10801 Craighead Dr.<br>Houston, TX 77025<br>Ph: 855-696-7254<br>Fax: [phone] |
|-------------------|----------------------------------------------------------------------------------------------------------|
| Contact Person: | Brian Pikkula, PhD |
| Date Prepared: | November 22, 2022 |
| Proprietary Name: | PerioStom™ Dental Dressing |
| 510(k) Number: | K221428 |
| Common Name: | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic |
| Device Class: | Unclassified (Pre-Amendment) |
| Panel: | General & Plastic Surgery |
| Product Code: | MGQ |
| Predicate: | HemCon® Dental Bandage (K060363) |

#### Device Description:

PerioStom™ Dental Dressing is a powder based wound dressing comprised entirely of spray-dried chitosan. PerioStom™ Dental Dressing is provided to the clinician in a stainless steel container and can be applied to the tissue via a dental instrument of their choice (e.g. a Prichard or Howard Periosteal Elevator) or a dry gloved finger. PerioStom™ Dental Dressing is also supplied in preloaded cartridges for application to harder to reach areas of the oral mucosa via the FS Dispenser™.

#### Indications For Use:

PerioStom™ Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.

#### Intended Use:

PerioStom™ Dental Dressing can be utilized for the pain relief and protection of oral mucosa due to irritation, trauma, or following iatrogenic procedures such as scaling and root planing.

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## Forward Science LLC

#### Substantial Equivalence

PerioStom™ Dental Dressing is technologically equivalent to the predicate device, Hemcon Dental Dressing; both are dried chitosan based dressings that are applied to oral mucosal surfaces. Both devices, when exposed to saliva, blood or crevicular fluids, become a bioadherent gel acting as a physical barrier for the mucosal tissue.

PerioStom™ Dental Dressing is substantially equivalent to Hemcon Dental Dressing as evidenced in Table 1. There are no technological differences between the subject and predicate devices.

Both the subject device and the predicate consist of chitosan that when exposed to oral fluids form a protective layer over the compromised mucosa. Both PerioStom™ Dental Dressing and Hemcon Dental Dressing provide pain relief by coating damaged mucosa and protecting it from further contamination and irritation. Therefore, PerioStom™ Dental Dressing and its predicate, Hemcon Dental Dressing, are substantially equivalent.

| Comparison<br>Parameters | Subject Device | Predicate |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| | PerioStom™ | HemCon Dental Bandage<br>(K060363) |
| Intended Use | oral wound dressing intended as a<br>physical barrier for temporary<br>protection of oral mucosal tissue and<br>to provide pain relief | oral wound dressing intended as a<br>physical barrier for temporary<br>protection of oral mucosal tissue and<br>to provide pain relief |
| Area of Use | Oral Mucosa | Oral Mucosa |
| Chemical<br>Characteristics | Dried chitosan | Dried chitosan |
| Applications | Once per wound | Use as needed |
| Use | Single use | Single use |
| Prescription/OTC | Prescription | Prescription |
| Intended User | Dental Professional | Dental Professional |
| Type of Product | Ready for use | Ready for use |

#### Table 1. Comparison of Subject Device and Predicates

#### Non-clinical Performance Testing:

Bench testing comparing PerioStom™ Dental Dressing and Hemcon Dental Dressing were performed. The results were substantially equivalent for PerioStom and the predicate, providing further evidence of substantial equivalence. The testing consisted of:

- Viscosity
- pH
- Microbial Testing
- Wound Barrier Testing ●

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## Forward Science LLC

10810 Craighead Dr. Houston, TX 77025 USA Ph: 855-696-7254

#### Biocompatibility:

In vitro and in vivo biocompatibility testing according to ISO 10993 standards for Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity were performed. The testing demonstrated that PerioStom™ Dental Dressing met the ISO 10993 requirements for biocompatibility.

#### Clinical Performance Testing:

No clinical performance testing was conducted.

#### Conclusions:

Based upon technologic characteristics as well as the results of comparative non-clinical performance testing, and in vitro & in vivo biocompatibility testing, we believe that PerioStom™ Dental Dressing is substantially equivalent to the predicate K060363.