Fluoride Varnish (Type A,Type C)
Device Facts
| Record ID | K253052 |
|---|---|
| Device Name | Fluoride Varnish (Type A,Type C) |
| Applicant | Nagy Oral Technology Qinhuangdao Co., Ltd. |
| Product Code | LBH · Dental |
| Decision Date | Jun 11, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3260 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Fluoride Varnish is indicated to relieve dental hypersensitivity.
Device Story
Fluoride Varnish is a flavored, xylitol-sweetened topical dental product applied to exposed dentin surfaces to treat hypersensitivity. Available as Type A (5% sodium fluoride) or Type C (1.33% sodium fluoride). Delivered in single-dose packages (pouch with brush) or multi-dose containers (aluminum tube or LDPE bottle). Applied by dental professionals in a clinical setting. Operates by forming a protective coating on the tooth surface to occlude dentinal tubules. Provides relief from sensitivity through fluoride-based mineral treatment and physical sealing of exposed dentin.
Clinical Evidence
No clinical data. Bench testing only. Evaluated per ISO 17730 for physical/mechanical properties (color, viscosity, density, pH, fluoride release/content, dentinal tubule occlusion). Biocompatibility assessed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-23 (irritation), and ISO 10993-11 (acute systemic toxicity).
Technological Characteristics
Resin-based topical fluoride varnish. Type A: 5% sodium fluoride; Type C: 1.33% sodium fluoride. Contains xylitol and flavoring agents. Non-sterile. Shelf life: 3 years. Evaluated per ISO 17730 and ISO 7405. Form factor: liquid/paste in single-dose pouches or multi-dose tubes/bottles.
Indications for Use
Indicated for patients requiring relief from dental hypersensitivity.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- ENAMELAST (K132109)
Reference Devices
- Dental Desensitizer (K222891)
Submission Summary (Full Text)
{0}
**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 11, 2026
Nagy Oral Technology Qinhuangdao Co., Ltd.
% Boyle Wang
General Manager
Shanghai Truthful Information Technology Co., Ltd.
Room 1801
No. 161 East Lu Jiazui Rd.Pudong
Shanghai, 200120
China
Re: K253052
Trade/Device Name: Fluoride Varnish (Type A,Type C)
Regulation Number: 21 CFR 872.3260
Regulation Name: Cavity Varnish
Regulatory Class: Class II
Product Code: LBH
Dated: May 14, 2026
Received: May 14, 2026
Dear Boyle Wang:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K253052 - Boyle Wang
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled 'Deciding When to Submit a 510(k) for a Change to an Existing Device' (https://www.fda.gov/media/99812/download) and 'Deciding When to Submit a 510(k) for a Software Change to an Existing Device' (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ('UDI Rule'). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, 'Misbranding by reference to premarket notification' (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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
{2}
K253052 - Boyle Wang
Page 3
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,
Bobak
Shirmohammadi -S
For Michael E. Adjodha, M.ChE., RAC, CQIA
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
{3}
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K253052
Device Name
Fluoride Varnish (Type A, Type C)
Indications for Use (Describe)
The Fluoride Varnish is indicated to relieve dental hypersensitivity.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 441-6740 EF
{4}
510(k) Summary
# 510(k) Summary
K253052
This summary is submitted in accordance with 21 CFR 807.92.
### 1.0 Submission Sponsor
Name: Nagy Oral Technology Qinhuangdao Co., Ltd.
Address: No.9 Dushan Road, Economic and Technological Development Zone,
Qinhuangdao City, 066004 Hebei P.R.China
Contact: Li Na
Tel: +86-18833870105
Email: aidite-zc@aidite.com
### Designated Submission Correspondent
Contact: Mr. Boyle Wang
Address: Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lu Jiazui Rd., Pudong Shanghai,
200120 China
Tel: +86-21-50313932
Email: info@truthful.com.cn
Date of Preparation: June 11,2026
### 2.0 Device Information
Trade name: Fluoride Varnish
Common name: Fluoride Varnish
Classification name: Varnish, Cavity
Production code: LBH
Regulation number: 21 CFR 872.3260
Classification: Class II
Panel: Dental
### 3.0 Identification of Predicate Device and Reference Device
#### Predicate#
510(k) Number: K132109
Trade/Product Name: ENAMELAST
Manufacturer: ULTRADENT PRODUCTS INC. / ORATECH LLC
1 of page 5
{5}
510(k) Summary
# **Reference#**
510(k) Number: K222891
Trade/Product Name: Dental Desensitizer
Manufacturer: Guangzhou Beogene Biotech Co., Ltd.
# **4.0 Device Description**
The subject device, Fluoride Varnish, is a flavored, xylitol-sweetened topical fluoride dental product supplied in liquid/paste form. It is applied to exposed dentin surfaces for the purpose of treatment dentinal hypersensitivity.
It is available in two types: Type A (5% Sodium Fluoride) and Type C (1.33% Sodium Fluoride). The device is delivered in either single-dose packages (aluminum foil pouch containing dental brush, and fluoride varnish) or multi-dose packages (type A: composite aluminum tube).type C (LDPE Bottle, tray and dental brush)
# **5.0 Indication for Use Statement**
The Fluoride Varnish is indicated to relieve dental hypersensitivity.
# **6.0 Non-clinical Test Conclusion**
Bench Testing:
• Physical and mechanical properties of the subject device were evaluated according to FDA-recognized version ISO 17730 Dentistry - Fluoride varnishes.
Performance testing including color, viscosity, density, PH, fluoride release, fluoride contents and dentinal tubule occlusion.
The test results demonstrated the Subject device meets the property requirements of the referenced standards.
Biocompatibility Testing:
The Fluoride Varnish was assessed as a surface medical device in contact with mucosal membrane for less than or equal to 24 hours. The biocompatibility testing was performed according to FDA currently-recognized versions of biocompatibility consensus standards ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and ISO 7405:2018 Dentistry – Evaluation of biocompatibility of medical devices used in dentistry.
The following biological safety aspects have been addressed:
- Cytotoxicity – ISO 10993-5
- Sensitization – ISO 10993-10
- Irritation – ISO 10993-23
- Acute Systemic Toxicity- ISO 10993-11
2 of page 5
{6}
510(k) Summary---
Sterility and Shelf-Life Testing:
The device is provided non-sterile.
From the Shelf life testing, the subject Fluoride Varnish has a shelf life of 3 years.
### **7.0 Technological Characteristics and Substantial Equivalence**
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
**Table 1- Comparison of Technology Characteristics**
3 of page 5
{7}
510(k) Summary
| Item | Subject Device | Predicate Device | Reference Device | Remark |
| --- | --- | --- | --- | --- |
| 510(k) No. | K253052 | K132109 | K222891 | |
| Product Name | Fluoride Varnish | Enamelast™ | Dental Desensitizer | -- |
| Product Code | LBH | LBH | LBH | Same |
| Regulation No. | 21 CFR 872.3260 | 21 CFR 872.3260 | 21 CFR 872.3260 | Same |
| Class | Class II | Class II | Class II | Same |
| Intended Use/ Indication for Use | The Fluoride Varnish is indicated to relieve dental hypersensitivity. | Enamelast™ Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity. | 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. | Same* All three devices are indicated for use in the treatment of hypersensitive teeth. |
| Prescription or OTC | Prescription Use | Prescription Use | Prescription Use | Same |
| Intended user | Dental professional | Dental professional | Dental professional | Same |
| Materials | Type A –5% sodium fluoride Resin based; Type C –1.33% sodium fluoride Resin based | 5% sodium fluoride Resin based | 3% Potassium Nitrate; 0.11% w/w Fluoride Ion 1200 ppm | Different Different questions of safety or effectiveness are not raised because significant concerns are not raised. The amount of fluoride ions between the subject and reference device is similar. |
| Amount of fluoride Ion | Type A: 22,500 ppm Type C: 6000 ppm | 22,500 ppm | | |
| Physical properties | Appearance: Light yellow; Odor: Fruit flavor State: Type A – paintable | Appearance: White resinous material Odor: Bubble gum or Mint PH: Mint -2.95 | Appearance: Colorless, odourless, transparent gel, no visible impurity | Different The difference due to the different components. |
4 of page 5
{8}
510(k) Summary
| | paste; Type C – paintable liquid PH:4-8 Shelf Life: 36 months | Shelf Life: 18 months | PH: 6-7.5 Shelf Life: 24 months | The essential design of these products is the same. All three products are formulated with a polymer that coats the teeth, a fluoride mineral, a solvent to dissolve the fluoride mineral, and additives such as flavoring agents and rheology modifiers. So different questions of safety or effectiveness are not raised. |
| --- | --- | --- | --- | --- |
| Sterile | Non-sterile | Non-sterile | Non-sterile | 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(Cytotoxicity) | Passed the tests as per ISO 10993-5, ISO 10993-10 and ISO 10993-11 (Cytotoxicity, sensitization, irritation, acute systemic toxicity) | Same |
## **8.0 Summary of Clinical Test**
Clinical testing was not required for this submission.
## **9.0 Conclusion**
The conclusions drawn from the comparison and analysis above demonstrate that the subject device is substantially equivalent to the legally marketed predicated device.
5 of page 5
