Gingi-Aid Gel

• K Number: K211419
• Device Name: Gingi-Aid Gel
• Manufacturer: Belport Company, Inc., Gingi-Pak
• Date Cleared: 2022-01-10 ( 248 days)
• Product Code: MVL
• Regulation Number: N/A

Intended Use

GINGI-AID Gel is intended for gingival retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry when used with gingival retraction cords. The gel facilitates the insertion of the cord into the sulcus.

Device Description

Gingi-Aid Gel is a 25% Aluminum Chloride in a water-based, viscous gel that facilitates gingival 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. Gingi-Aid 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

K193389

Reference Devices

K123215

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly define a chemical-based gel for physical gingival retraction and bleeding control. There is no mention of any computational or analytical functions that would involve AI/ML.

Therapeutic

No.
The device is used for gingival retraction and to control bleeding, which are mechanical and chemical actions, not therapeutic in the sense of treating a disease or restoring health.

Diagnostic

No

The device is intended for gingival retraction and to control bleeding/oozing, which are therapeutic or preparatory actions, not diagnostic ones. It does not identify or characterize a disease or condition.

SaMD (Software as a Medical Device)

No

The device is a gel supplied in syringes, which are physical components, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for gingival retraction and controlling bleeding/oozing in the oral cavity during dental procedures. This is a direct application to the patient's tissue.
• Device Description: The device is a gel applied to the sulcus for physical displacement and barrier creation. It's a topical application.
• Lack of In Vitro Testing: The description of performance studies focuses on biocompatibility and chemical content, not on testing biological samples outside the body to diagnose or monitor a condition.
• Anatomical Site: The anatomical site is the oral cavity, indicating direct application to the patient.

IVD devices are designed to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

GINGI-AID Gel is intended for gingival retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry when used with gingival retraction cords. The gel facilitates the insertion of the cord into the sulcus.

Product codes (comma separated list FDA assigned to the subject device)

MVL

Device Description

Gingi-Aid Gel is a 25% Aluminum Chloride in a water-based, viscous gel that facilitates gingival 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.

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

Healthcare facility/ Dental office / Health care professionals

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, no skin sensitization or skin irritation.
Bench Testing: Gingi-Aid Gel has been tested for aluminum chloride content and is found to be similar to predicate device.
Sterility and Shelf-Life Testing: Gingi-Aid Gel is not supplied as sterile. Based on accelerated testing, a shelf life of two years is supported for Gingi-Aid Gel. Real time aging is being performed on Gingi-Aid to support shelf life during typical storage conditions.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K193389

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K123215

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

N/A

Summary

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January 10, 2022

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

Re: K211419

Trade/Device Name: Gingi-Aid Gel Regulatory Class: Unclassified Product Code: MVL Dated: November 22, 2021 Received: November 29, 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/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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, 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) K211419

Device Name GINGI-AID Gel

Indications for Use (Describe)

GINGI-AID Gel is intended for gingival retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry when used with gingival retraction cords. The 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:	Xiaowen Xu
Email:	[e-mail]
Tel:	[phone]
Date Prepared:	07/08/2020
II. Device
Device Trade Name:	GingiAid Gel
Common and
Classification Names(s):	Cord, Retraction
Device Classification:	Unclassified
Product Code:	MVL
III. Predicate Device(s)
Predicate Device Trade
Name:	Vista Clear
510 (k) Number:	K193389
Submitter:	Inter-Med/ Vista Dental Products
Device Classification:	Unclassified
Product Code:	MVL
Reference Device Trade
Name:	ViscoStat Clear
510 (k) Number:	K123215
Submitter:	Ultradent Products
Device Classification:	Unclassified
Product Code:	MVL

510(k) Summary-K211419

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IV. Device Description
Device Identification:	25 % Aluminum Chloride in a water-based, viscous gel
Device Characteristic:	Gingi-Aid 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:	Gingi-Aid Gel is a 25% Aluminum Chloride in a water-based, viscous gel that facilitates gingival 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:	Aluminum Chloride in a water-based gel
V. Indications for Use
Gingi-Aid 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. Gingi-Aid Gel facilitates the insertion of the cord into the sulcus.
VI. Comparison of Technological Characteristics with the Predicate Device
	Predicate Device:
Vista Clear	Reference Device:
ViscoStat Clear	Subject Device:
Gingi-Aid Gel
510(k) Number	K193389	K123215	K211419
Common Name	Cord, Retraction	Cord, Retraction	Cord, Retraction
Device Classification	Unclassified	Unclassified	Unclassified
Product Code	MVL	MVL	MVL
Indication for Use	Vista Clear is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in	ViscoStat Clear is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in	GINGI-AID Gel is intended for gingival retraction prior to impression making and to control bleeding and gingival oozing in
	restorative and
operative
dentistry used
with gingival
retraction cord.
Vista Clear
facilitates the
insertion of the
cord into the
sulcus.	restorative and
operative
dentistry used
with gingival
retraction cord
and/or the Dento
Infusor. These
gels facilitate the
insertion of the
cord into the
sulcus.	restorative and
operative
dentistry used
when with
gingival retraction
cord. The 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	26.6% Aluminum
Chloride
Hexahydrate	25% Aluminum
Chloride	25% Aluminum
Chloride
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.
pH	unknown	2.65	2.62
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	24 months	42 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, no skin
sensitization or skin irritation.
Bench Testing	Gingi-Aid Gel has been tested for aluminum chloride
content and is found to be similar to predicate device.
	Gingi-Aid Gel is not supplied as sterile.
Sterility and
Shelf-Life Testing	Based on accelerated testing, a shelf life of two years is
supported for Gingi-Aid Gel. Real time aging is being
performed on Gingi-Aid to support shelf life during typical
storage conditions.
VIII. Conclusion
Gingi- Aid is determined to be substantially equivalent to Vista Clear (K193389). 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 Gingi-Aid Gel is substantially equivalent to the predicate device, Vista Clear.