Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a chemical gel for treating tooth sensitivity and does not mention any AI or ML components or functionalities.

Therapeutic

Yes
The device is used to directly relieve dentin allergy by sealing exposed dentin tubules, which constitutes a therapeutic effect.

Diagnostic

No.
The Dental Desensitizer is described as a gel applied to the tooth to relieve dentin allergy by sealing exposed dentin tubules, which indicates a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device is described as a gel, which is a physical substance, not software. The description focuses on its chemical composition and physical properties.

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 to treat dentin sensitivity by forming a film on the tooth and sealing exposed dentin tubules. This is a therapeutic action performed directly on the patient's tooth.
Mechanism of Action: The device works by physically sealing the dentin tubules and delivering potassium nitrate and fluoride to the tooth surface. This is a direct treatment, not a diagnostic test performed on a sample from the body.
Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, measure a substance in a biological sample, or provide information for diagnostic purposes.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Dental Desensitizer is a colorless transparent gel that is applied to the sensitive part of the tooth to form a film, sealing the exposed dentin tubules and relieving dentin allergy. The product is used either by a dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.

Product codes

LBH

Device Description

Dental Desensitizer is a sustained release, 3% potassium nitrate and 0.11% weight fluoride ion, viscous gel. This product is designed to be used together with a custom-fabricated tray.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

tooth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental professional in the dental office or patient for home treatment

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

Non-clinical testings have been conducted to verify that the Dental Desensitizer meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device.

Performance Test Report: A performance verification test was performed to analyze treatment effect of Dental Desensitizer during patient treatment, and to validate that the output meets design specifications and demonstrate that the treatment effect of Dental Desensitizer is expected compared to the predicate device. Properties evaluated include appearance, loading capacity, potassium content, fluoride content, total heavy metal content, arsenic content, PH value, microbial limit, and dentin tubule occlusion comparative test.

Shelf Life Test Report: Shelf life testing was conducted by evaluating the physical properties of the device to confirm a shelf life at room temperature of 24 months.

Biocompatibility: A biocompatibility discussion was conducted. The Dental Desensitizer has been tested and shown to be compliant with the following standards:

ISO 7405, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
A ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
A ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity
A ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
ISO 10993-11, Biological Evaluation of Medical Devices - Part 11: Tests For Systemic Toxicity

Key Metrics

Not Found

Predicate Device(s)

K061438

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3260 Cavity varnish.

(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

May 25, 2023

Guangzhou Beogene Biotech Co., Ltd % Tracy Che Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center No. 3101-90. Oianhai Road ShenZhen, GuangDong 518052 CHINA

Re: K222891

Trade/Device Name: Dental Desensitizer Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: LBH Dated: March 29, 2023 Received: March 29, 2023

Dear Tracy Che:

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.

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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K22891

Device Name Dental Desensitizer

Indications for Use (Describe)

The Dental Desensitizer is a colorless transparent gel that is applied to the sensitive part of the tooth to form a film, sealing the exposed dentin tubules and relieving dentin allergy. The product is used either by a dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.

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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510 (k) Summary

This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.

(1) Applicant information

510 (k) owner's name:	Guangzhou Beogene Biotech CO., Ltd
Address:	Second floor, Building C, Self-compiled (1) Building, No.2 Ruita
Road, Huangpu District, Guangzhou, China
Contact person:	Duan Qiangqiang
Phone number:	+86-16626708885
Fax number:	+86-020-32029939
Email:	2885151672@qq.com
Date of summary prepared:	2023-3-29
Reason for the submission:	New device, there were no prior submissions for the device.

(2) Proprietary name of the device

Trade name/Model:	Dental Desensitizer
Common name	Tooth Desensitizer
Regulation name:	Varnish, Cavity
Regulation number:	21 CFR 872.3260
Product code	LBH
Review panel:	Dental
Regulation class:	Class II

(3) Predicate device

Sponsor	Ultradent Products, Inc.
Device Name and Model	UltraEZ Desensitizing Gel
510(k) Number	K061438
Product Code	LBH
Regulation Number	21 CFR 872.3260
Regulation Class	II

(4) Description/ Design of device

Dental Desensitizer is a sustained release, 3% potassium nitrate and 0.11% weight fluoride ion, viscous gel. This product is designed to be used together with a custom-fabricated tray.

4

(5) Intended use/ Indications for use

The Dental Desensitizer is a colorless transparent gel that is applied to the sensitive part of the tooth to form a film, sealing the exposed dentin tubules and relieving dentin allergy. The product is used either by a dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.

(6) Materials

| Component name | Body Contact Category
(ISO 10993-1) | Contact Duration
(ISO 10993-1) |
|---------------------|------------------------------------------------------|-----------------------------------|
| Dental Desensitizer | External communicating device:
tissue/bone/dentin | Permanent contact >30 d |

The Dental Desensitizer has passed biocompatibility tests. Details can be seen in "Biocompatibility Discussion".

(7) Technological characteristics and substantial equivalence

Item	Subject device	Predicate device	Remark
Trade name	Dental Desensitizer	UltraEZ Desensitizing Gel	/
510 (k) number	/	K061438	/
Regulation
number	21 CFR 872.3260	21 CFR 872.3260	Same
Regulation name	Varnish, Cavity	Varnish, Cavity	Same
Product code	LBH	LBH	Same
Class	II	II	Same
Indications for
use/ Intended use	The Dental Desensitizer is a
colorless transparent gel that is
applied to the sensitive part of
the tooth to form a film, sealing
the exposed dentin tubules and
relieving dentin allergy. The
product is used either by a dental
professional in the dental office
or provided to the patient for
home treatment of dentin
sensitivity	The UltraEZ Desensitizing
Gel provides a film-like
varnish for sensitive teeth,
sealing dentinal tubules of
over exposed dentin and other
exposed areas where
post-operative or other dentin
sensitivity is a concern. The
product is used either by a
dental professional in the
dental office or provided to the
patient for home treatment of
dentin sensitivity	The
descripti
on is
different
compare
d to the
predicate
device, it
is
actually
the same.
Prescription or
OTC	Prescription Use	Prescription Use	Same
Scope of use	Hospital, dental office, or home
treatment	Dental office or home
treatment	Same

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| Design | Designed to be used together
with a custom-fabricated dental
tray. | Designed to be used in a
custom-fabricated dental tray. | Same |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------|
| Materials | 3% Potassium Nitrate;
0.11% w/w Fluoride Ion | 3% Potassium Nitrate;
0.11% w/w Fluoride Ion | Same |
| Appearance | Colorless, odourless,
transparent gel, no visible
impurity | Colourless, Odourless, Gel | Same |
| PH-value | 6-7.5 | 6-7.5 | Same |
| Recommended
contact time | Treatment 15-60 mins | Treatment 15-60 mins | Same |
| Device
description | Immediate physical blockage
of dentinal tubules to eliminate
painful sensitivity. | Immediate physical blockage
of dentinal tubules to eliminate
painful sensitivity. | Same |
| Biocompatibility | Passed the tests as per ISO
10993-5, ISO 10993-10 and
ISO 10993-11
(Cytotoxicity, sensitization,
irritation, acute systemic
toxicity) | Passed the tests as per ISO
10993-5 and ISO 10993-10
(Cytotoxicity, sensitization,
irritation) | Similar |
| Sterility | Non-sterile | Non-sterile | Same |

Conclusion:

Based on the above analysis, the Dental Desensitizer is substantial equivalent to the predicate device.

(8) Non-clinical studies and tests performed

Non-clinical testings have been conducted to verify that the Dental Desensitizer meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device.

Performance Test Report

A performance verification test was performed to analyze treatment effect of Dental Desensitizer during patient treatment, and to validate that the output meets design specifications and demonstrate that the treatment effect of Dental Desensitizer is expected compared to the predicate device. Properties evaluated include appearance, loading capacity, potassium content, fluoride content, total heavy metal content, arsenic content, PH value, microbial limit, and dentin tubule occlusion comparative test.

Shelf Life Test Report

Shelf life testing was conducted by evaluating the physical properties of the device to confirm a shelf life at room temperature of 24 months.

Biocompatibility

6

A biocompatibility discussion was conducted. The Dental Desensitizer has been tested and shown to be compliant with the following standards:

ISO 7405, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
A ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
A ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity
A ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
ISO 10993-11, Biological Evaluation of Medical Devices - Part 11: Tests For Systemic Toxicity

(9) Clinical studies and tests performed

Clinical studies and tests were not conducted.

(10) Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the Dental Desensitizer is to be concluded substantial equivalent to its predicate devices.