Stasis Gel

K211420 · Belport Company, Inc., Gingi-Pak · MVL · Mar 14, 2022 · DE

Device Facts

• Record ID: K211420
• Device Name: Stasis Gel
• Applicant: Belport Company, Inc., Gingi-Pak
• Product Code: MVL · DE
• Decision Date: Mar 14, 2022
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

STASIS Gel is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. STASIS Gel facilitates the insertion of the cord into the sulcus.

Device Story

Stasis Gel is a 15.5% ferric sulfate water-based viscous gel used in dental offices by healthcare professionals. It is applied to the gingival sulcus to provide physical tissue displacement and a barrier against bleeding and oozing. The gel facilitates the insertion of gingival retraction cords prior to dental impression procedures. It is supplied in 1.2 ml or 30 ml plastic syringes with applicator tips. The device acts as a mechanical aid for tissue management during restorative and operative dental procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 demonstrated low cytotoxicity, skin sensitization, and skin irritation. Ferric sulfate content verified as similar to predicate. Shelf-life of 24 months supported by accelerated aging testing.

Technological Characteristics

15.5% Ferric Sulfate in water-based viscous gel; viscosity ≥ 55,000 cps; pH 1-3. Supplied in 1.2 ml or 30 ml plastic syringes. Non-sterile. Biocompatibility tested per ISO 10993-1.

Indications for Use

Indicated for sulcus retraction prior to impression making and control of bleeding/gingival oozing in restorative and operative dentistry, used in conjunction with gingival retraction cord by healthcare professionals.

Predicate Devices

• Vista FS (K190220)

Reference Devices

• Vista FS Liquid (K190220)

Submission Summary (Full Text)

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March 14, 2022

Belport Company, Inc., Gingi-Pak Mohammed Islam Director of R&D 4825 Calle Alto Camarillo, California 93012

Re: K211420

Trade/Device Name: Stasis Gel Regulatory Class: Unclassified Product Code: MVL Dated: June 29, 2021 Received: July 23, 2021

Dear Mohammed Islam:

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/cfpmp/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 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

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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 medical devices and radiation-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,

For 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) K211420

Device Name STASIS Gel

Indications for Use (Describe)

STASIS Gel is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. STASIS Gel facilitates the insertion of the cord into the sulcus.

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)

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| I. SUBMITTER | |
|--------------------------------------------|----------------------------------------|
| Name: | Gingi-Pak, a Division of Belport Co. |
| Address: | 4825 Calle Alto<br>Camarillo, CA 93012 |
| Contact Person: | Summeya Islam |
| Email: | [e-mail] |
| Tel: | [phone] |
| Date Prepared: | 01/12/2021 |
| II. Device | |
| Device Trade Name: | Stasis Gel |
| Common and<br>Classification Names<br>(s): | Cord, Retraction |
| Device Classification: | Unclassified |
| Product Code: | MVL |
| III. Predicate Device(s) | |
| Predicate Device Trade<br>Name: | Vista FS |
| 510 (k) Number: | K190220 |
| Submitter: | Inter-Med/ Vista Dental Products |
| Device Classification: | Unclassified |
| Product Code: | MVL |
| Reference Device Trade<br>Name: | Vista FS Liquid |
| 510 (k) Number: | K190220 |
| Submitter: | Inter-Med/ Vista Dental Products |
| Device Classification: | Unclassified |
| Product Code: | MVL |

## 510(k) Summary - K211420

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| IV. Device Description | | | |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Identification: | 15.5% Ferric Sulfate in a water-based, viscous gel | | |
| Device Characteristic: | Stasis Gel is supplied in a 30 ml or 1.2 ml plastic syringe.<br>The 30 ml syringe is used for bulk storage and 1.2 ml<br>plastic syringe is used for delivery the gel to the sulcus. | | |
| Environment of Use: | Healthcare facility/ Dental office | | |
| Summary (Description) of Device: | Stasis Gel is a 15.5% Ferric Sulfate in a water-based,<br>viscous gel that facilitates sulcus retraction. When applied<br>to the sulcus, the product provides physical displacement<br>of the gingival tissue from the tooth, which in turn, provides<br>a physical barrier to prevent gingival bleeding and oozing<br>from following procedures. | | |
| Material of Use: | Ferric Sulfate in a water-based gel | | |
| V. Indications for Use | | | |
| | Stasis Gel is intended for sulcus retraction prior to<br>impression making and to control bleeding and gingival<br>oozing in restorative and operative dentistry used with<br>gingival retraction cord. Stasis Gel facilitates the insertion<br>of the cord into the sulcus. | | |
| VI. Comparison of Technological Characteristics with the Predicate Device | | | |
| | Predicate Device:<br>Vista FS | Reference Device:<br>Vista FS Liquid | Subject Device:<br>Stasis Gel |
| | Oral Cavity | Oral Cavity | Oral Cavity |
| 510(k) Number | K190220 | K190220 | K211420 |
| Common Name | Cord, Retraction | Cord, Retraction | Cord, Retraction |
| Device Classification | Unclassified | Unclassified | Unclassified |
| Product Code | MVL | MVL | MVL |
| Indication for Use | Vista FS is<br>intended for<br>sulcus retraction | Vista FS<br>Liquid is intended<br>for sulcus<br>retraction | Stasis Gel is<br>intended for<br>sulcus retraction |
| | prior to<br>impression<br>making and to<br>control bleeding<br>and gingival<br>oozing in<br>restorative and<br>operative<br>dentistry used<br>with gingival<br>retraction cord.<br>Vista FS<br>facilitates the<br>insertion of the<br>cord into the<br>sulcus. | prior to<br>impression<br>making and to<br>control<br>bleeding and<br>gingival<br>oozing in<br>restorative<br>and operative<br>dentistry used<br>with<br>gingival retraction<br>cord. This device<br>facilitate the<br>insertion<br>of the cord into<br>the<br>sulcus. | prior to<br>impression<br>making and to<br>control bleeding<br>and gingival<br>oozing in<br>restorative and<br>operative<br>dentistry used<br>with gingival<br>retraction cord.<br>Stasis Gel<br>facilitates the<br>insertion of the<br>cord into the<br>sulcus. |
| Environment of Use | Healthcare offices<br>/ Dental offices | Healthcare offices<br>/ Dental offices | Healthcare offices<br>/ Dental offices |
| Target Population | Health care<br>professionals | Health care<br>professionals | Health care<br>professionals |
| Prescription/ OTC | Prescription | Prescription | Prescription |
| Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity |
| Chemical<br>Characteristics | 20% Ferric<br>Sulfate | 15.5% Ferric<br>Sulfate | 15.5% Ferric<br>Sulfate |
| Mechanism of Action | Placement of the<br>viscous gel<br>results in physical<br>displacement of<br>gingival tissue<br>from the tooth.<br>Material also<br>facilitates<br>insertion of the<br>cord into the<br>sulcus. | Placement of the<br>viscous gel<br>results in physical<br>displacement of<br>gingival tissue<br>from the tooth.<br>Material also<br>facilitates<br>insertion of the<br>cord into the<br>sulcus. | Placement of the<br>viscous gel<br>results in physical<br>displacement of<br>gingival tissue<br>from the tooth.<br>Material also<br>facilitates<br>insertion of the<br>cord into the<br>sulcus. |
| Viscosity | Unknown | Unknown | ≥ 55,000 cps |
| pH | Unknown | 1-3 | 1-3 |
| | | | |
| Packaging Configuration | 1.2mL pre-filled<br>syringe with<br>applicator tips;<br>30mL syringe with<br>empty 1.2mL<br>syringes and<br>applicator tips. | 1.2mL pre-filled<br>syringe with<br>applicator tips;<br>30mL syringe with<br>empty 1.2mL<br>syringes and<br>applicator tips | 1.2mL pre-filled<br>syringe with<br>applicator tips;<br>30mL syringe<br>with empty 1.2mL<br>syringes and<br>applicator tips. |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Shelf-Life | 18 months | 18 months | 24 months |
| Recommended Contact<br>Time | 1-3 minutes | 1-3 minutes | 1-3 minutes |
| Biocompatibility | Cytotoxicity | Cytotoxicity | Cytotoxicity<br>Skin Sensitization<br>Skin Irritation |
| VII. Summary of Testing (Non-Clinical) | | | |
| Biocompatibility | Biocompatibility testing are performed according to ISO<br>10993-1. Device demonstrated low cytotoxicity, skin<br>sensitization and skin irritation. | | |
| Bench Testing | Stasis Gel has been tested for Ferric Sulfate content and<br>is found to be similar to predicate device. | | |
| Sterility and<br>Shelf-Life Testing | Stasis Gel is not supplied as sterile. | | |
| | Based on accelerated testing, a shelf life of two years is | | |
| | supported for Stasis Gel. Real time aging is being<br>performed on Stasis Gel to support shelf life during typical<br>storage conditions. | | |
| VIII. Conclusion | | | |
| Stasis Gel is determined to be substantially equivalent to Vista FS (K190220). The | | | |

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subject medical device has a nearly identical intended use and chemical characteristics and delivery system as the predicate device. Any differences between the subject medical device and predicate medical device do not significantly alter the product's use and do not result in unacceptable or unnecessary risks to the patients or users. Therefore, we conclude that Stasis Gel is substantially equivalent to the predicate device, Vista FS.