Stasis Gel

• K Number: K211420
• Device Name: Stasis Gel
• Manufacturer: Belport Company, Inc., Gingi-Pak
• Date Cleared: 2022-03-14 ( 311 days)
• Product Code: MVL
• Regulation Number: N/A

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 Description

Stasis Gel is a 15.5% Ferric Sulfate in a water-based, viscous gel that facilitates sulcus retraction. When applied to the sulcus, the product provides physical displacement of the gingival tissue from the tooth, which in turn, provides a physical barrier to prevent gingival bleeding and oozing from following procedures. Stasis Gel is supplied in a 30 ml or 1.2 ml plastic syringe. The 30 ml syringe is used for bulk storage and 1.2 ml plastic syringe is used for delivery the gel to the sulcus.

Predicate Devices

K190220

Reference Devices

K190220

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical composition and physical properties of the gel, with no mention of AI or ML.

Therapeutic

No
The device is described as facilitating sulcus retraction and controlling bleeding, which are procedural aids rather than direct treatments for a disease or condition. While it helps in dental procedures, its primary function isn't to cure, mitigate, treat, or prevent disease.

Diagnostic

No

The device description indicates STASIS Gel is used for physical sulcus retraction and to control bleeding and oozing, which are therapeutic and preparatory actions, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device is a gel supplied in syringes, indicating it is a physical substance and delivery system, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, STASIS Gel is NOT an In Vitro Diagnostic (IVD) device.

Here's why:

• Intended Use: The intended use clearly states that STASIS Gel is for sulcus retraction and controlling bleeding/oozing in the oral cavity during dental procedures. This is a direct application to the patient's tissue for a physical effect (retraction and hemostasis).
• Device Description: The description details a gel containing Ferric Sulfate applied to the sulcus for physical displacement and barrier creation. This is a topical application with a physical and chemical effect on the tissue.
• Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. STASIS Gel does not involve the analysis of such specimens.

In summary, STASIS Gel is a device used in vivo (on the living body) for a therapeutic/procedural purpose, not for diagnostic testing of biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

MVL

Device Description

Stasis Gel is a 15.5% Ferric Sulfate in a water-based, viscous gel that facilitates sulcus retraction. When applied to the sulcus, the product provides physical displacement of the gingival tissue from the tooth, which in turn, provides a physical barrier to prevent gingival bleeding and oozing from following procedures.

Stasis Gel is supplied in a 30 ml or 1.2 ml plastic syringe. The 30 ml syringe is used for bulk storage and 1.2 ml plastic syringe is used for delivery the gel to the sulcus.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral Cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Health care professionals / Healthcare facility/ Dental office

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Biocompatibility:
Biocompatibility testing are performed according to ISO 10993-1. Device demonstrated low cytotoxicity, skin sensitization and skin irritation.

Bench Testing:
Stasis Gel has been tested for Ferric Sulfate content and is found to be similar to predicate device.

Sterility and 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 performed on Stasis Gel to support shelf life during typical storage conditions.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K190220

Reference Device(s)

K190220

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

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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
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
Classification Names
(s):	Cord, Retraction
Device Classification:	Unclassified
Product Code:	MVL
III. Predicate Device(s)
Predicate Device Trade
Name:	Vista FS
510 (k) Number:	K190220
Submitter:	Inter-Med/ Vista Dental Products
Device Classification:	Unclassified
Product Code:	MVL
Reference Device Trade
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.
The 30 ml syringe is used for bulk storage and 1.2 ml
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,
viscous gel that facilitates sulcus retraction. When applied
to the sulcus, the product provides physical displacement
of the gingival tissue from the tooth, which in turn, provides
a physical barrier to prevent gingival bleeding and oozing
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
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.
VI. Comparison of Technological Characteristics with the Predicate Device
	Predicate Device:
Vista FS	Reference Device:
Vista FS Liquid	Subject Device:
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
intended for
sulcus retraction	Vista FS
Liquid is intended
for sulcus
retraction	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.
Vista FS
facilitates the
insertion of the
cord into the
sulcus.	prior to
impression
making and to
control
bleeding and
gingival
oozing in
restorative
and operative
dentistry used
with
gingival retraction
cord. This device
facilitate the
insertion
of the cord into
the
sulcus.	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.
Environment of Use	Healthcare offices
/ Dental offices	Healthcare offices
/ Dental offices	Healthcare offices
/ Dental offices
Target Population	Health care
professionals	Health care
professionals	Health care
professionals
Prescription/ OTC	Prescription	Prescription	Prescription
Anatomical Site	Oral Cavity	Oral Cavity	Oral Cavity
Chemical
Characteristics	20% Ferric
Sulfate	15.5% Ferric
Sulfate	15.5% Ferric
Sulfate
Mechanism of Action	Placement of the
viscous gel
results in physical
displacement of
gingival tissue
from the tooth.
Material also
facilitates
insertion of the
cord into the
sulcus.	Placement of the
viscous gel
results in physical
displacement of
gingival tissue
from the tooth.
Material also
facilitates
insertion of the
cord into the
sulcus.	Placement of the
viscous gel
results in physical
displacement of
gingival tissue
from the tooth.
Material also
facilitates
insertion of the
cord into the
sulcus.
Viscosity	Unknown	Unknown	≥ 55,000 cps
pH	Unknown	1-3	1-3
Packaging Configuration	1.2mL pre-filled
syringe with
applicator tips;
30mL syringe with
empty 1.2mL
syringes and
applicator tips.	1.2mL pre-filled
syringe with
applicator tips;
30mL syringe with
empty 1.2mL
syringes and
applicator tips	1.2mL pre-filled
syringe with
applicator tips;
30mL syringe
with empty 1.2mL
syringes and
applicator tips.
Sterility	Non-sterile	Non-sterile	Non-sterile
Shelf-Life	18 months	18 months	24 months
Recommended Contact
Time	1-3 minutes	1-3 minutes	1-3 minutes
Biocompatibility	Cytotoxicity	Cytotoxicity	Cytotoxicity
Skin Sensitization
Skin Irritation
VII. Summary of Testing (Non-Clinical)
Biocompatibility	Biocompatibility testing are performed according to ISO
10993-1. Device demonstrated low cytotoxicity, skin
sensitization and skin irritation.
Bench Testing	Stasis Gel has been tested for Ferric Sulfate content and
is found to be similar to predicate device.
Sterility and
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
performed on Stasis Gel to support shelf life during typical
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.