(169 days)
No.
The device description and supporting information do not mention any AI, DNN, or ML components. It is a chemical varnish for dental use, and its performance studies are based on laboratory evaluations of its physical and biological properties.
Yes
The device is indicated for the "relief of tooth hypersensitivity," which is a therapeutic purpose.
No
This device is a varnish intended for therapeutic relief of tooth hypersensitivity by mechanically occluding dentinal tubules, not for diagnosing a condition.
No
The device is a physical product (a cavity varnish composed of natural rosin, ethanol, etc.) intended for topical application, not a software application.
No.
The device is a topical dental varnish for hypersensitivity relief, applied directly to teeth, rather than a diagnostic tool used to examine specimens derived from the human body.
N/A
Intended Use / Indications for Use
Rennou™ Varnish is indicated for the relief of tooth hypersensitivity through the mechanical occlusion of dentinal tubules.
Product codes
LBH
Device Description
Rennou™ Varnish is a cavity varnish intended for professional use as a topical application on prepared tooth surfaces. This fluoride-free varnish creates a rosin-based film that prevents penetration of restorative material into the dentinal tissue and provides relief of tooth hypersensitivity by occluding open dentinal tubules. Unit-dose varnish and applicator are packaged together in individual thin, sealed trays. Rennou™ Varnish is only applied by a professional clinician.
Rennou™ Varnish is a topically applied flavored (Spearmint, etc.) compound comprised of natural rosin, ethanol, xylitol, and Rennou™ (a combination of theobromine, calcium acetate, and sodium hydrogen phosphate). The major components are rosin and ethanol, which, when delivered together, efficiently promote a fast-drying film on the tooth surface. The varnish is sweetened with xylitol.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth surfaces / dentinal tubules
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional clinician / dental practice
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)
Comprehensive laboratory studies evaluated Rennou™ Varnish for performance and biocompatibility. Enamel protection and dentinal hypersensitivity tests on molars and dentin specimens showed effective tubule occlusion, deep penetration, and a smooth surface finish, confirmed by SEM analysis. Cytotoxicity testing per ISO 10993-5 and USP showed acceptable biocompatibility, with Rennou™ Varnish exhibiting a slightly more favorable safety profile when tested directly against the primary predicate device. Additional testing was deemed unnecessary given the device's use of well-established rosin-based varnish technology in the market, documented safety of novel ingredients in dental applications, and substantial equivalence to predicates in both intended use and technological characteristics. The comprehensive risk analysis revealed no new questions of safety or effectiveness, as the device operates through the same mechanical principles as predicates while demonstrating a favorable safety profile, especially for children.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K140481, K082594, K080249, K080228
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
FDA 510(k) Clearance Letter - Rennou™ Varnish
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 27, 2025
Theodent, LLC
Andrew Fuselier
General Manager
1441 Canal Street
New Orleans, LA 70112
Re: K243777
Trade/Device Name: Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)
Regulation Number: 21 CFR 872.3260
Regulation Name: Cavity Varnish
Regulatory Class: Class II
Product Code: LBH
Dated: May 14, 2025
Received: May 15, 2025
Dear Andrew Fuselier:
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.
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K243777 - Andrew Fuselier 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 systems (QS) regulation (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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K243777 - Andrew Fuselier Page 3
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,
MICHAEL E. ADJODHA -S
Michael E. Adjodha, MChE, 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
Page 4
FORM FDA 3881 (6/20) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K1243777
Device Name: Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)
Indications for Use (Describe):
Rennou™ Varnish is indicated for the relief of tooth hypersensitivity through the mechanical occlusion of dentinal tubules.
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
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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."
Page 5
RENNOU™ VARNISH 510(K) SUMMARY
1441 Canal Street, New Orleans, Louisiana 70112, United States
1. SUBMITTER INFORMATION
Name: Theodent, LLC
Address: 1441 Canal Street
New Orleans, Louisiana 70112
Phone: (504) 264-5050 (504) 264-1885
Email: fuselier@theo-corp.com andrew@theo-corp.com
Contact: Joseph Fuselier Andrew Fuselier
Preparation Date: May 27, 2025
2. SUBMITTED DEVICE
Name of Device: Rennou™ Varnish
Classification Name: Cavity Varnish
Primary Product Code: 21 CFR 872.3260
Classification: Class II
Predicate Device: Colgate® Prevident Varnish (K132109)
3. DEVICE DESCRIPTION AND TECHNOLOGICAL CHARACTERISTICS
Rennou™ Varnish is a cavity varnish intended for professional use as a topical application on prepared tooth surfaces. This fluoride-free varnish creates a rosin-based film that prevents penetration of restorative material into the dentinal tissue and provides relief of tooth hypersensitivity by occluding open dentinal tubules. Unit-dose varnish and applicator are packaged together in individual thin, sealed trays. Rennou™ Varnish is only applied by a professional clinician.
Rennou™ Varnish is a topically applied flavored (Spearmint, etc.) compound comprised of natural rosin, ethanol, xylitol, and Rennou™ (a combination of theobromine, calcium acetate, and sodium hydrogen phosphate). The major components are rosin and ethanol, which, when delivered together, efficiently promote a fast-drying film on the tooth surface. The varnish is sweetened with xylitol.
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1441 Canal Street, New Orleans, Louisiana 70112, United States
4. INDICATIONS FOR USE
Rennou™ Varnish is indicated for the relief of tooth hypersensitivity through the mechanical occlusion of dentinal tubules.
5. TESTING SUMMARY
Comprehensive laboratory studies evaluated Rennou™ Varnish for performance and biocompatibility. Enamel protection and dentinal hypersensitivity tests on molars and dentin specimens showed effective tubule occlusion, deep penetration, and a smooth surface finish, confirmed by SEM analysis. Cytotoxicity testing per ISO 10993-5 and USP showed acceptable biocompatibility, with Rennou™ Varnish exhibiting a slightly more favorable safety profile when tested directly against the primary predicate device. Additional testing was deemed unnecessary given the device's use of well-established rosin-based varnish technology in the market, documented safety of novel ingredients in dental applications, and substantial equivalence to predicates in both intended use and technological characteristics. The comprehensive risk analysis revealed no new questions of safety or effectiveness, as the device operates through the same mechanical principles as predicates while demonstrating a favorable safety profile, especially for children.
| Rennou™ Varnish | Colgate Prevident Varnish | Colgate Desensitizing Mouthwash | Remedent NV Remesense | Ultradent Flor-Opal Varnish | Novamin Oralief Toothpaste | Comments | |
|---|---|---|---|---|---|---|---|
| Device | Submitted Device | Primary Predicate | Reference Device | Reference Device | Reference Device | Reference Device | Reference devices were included to highlight the various approved cavity varnishes containing novel ingredients for occlusion benefit. |
| 510(k) number | K243777 | K132109 | K140481 | K082594 | K080249 | K080228 | |
| Indication for use (abbreviated) | Treatment of dental hypersensitivity | Treatment of dental hypersensitivity | Treatment of dental hypersensitivity | Treatment of dental hypersensitivity | Treatment of dental hypersensitivity | Treatment of dental hypersensitivity | Indications for Use are consistent amongst all devices. |
| Product Design | Cavity varnish | Cavity varnish | Mouthwash | Foam Strips | Cavity Varnish | Toothpaste | While product designs differ amongst the devices, our product design is the same as the primary predicate device. |
| Chemical Composition | Rosin, Ethanol, Xylitol, Theobromine, Calcium Acetate, Sodium Hydrogen Phosphate, Flavor | Rosin, Ethanol, Xylitol, Sodium Fluoride, Hexadecane Phosphate, Citric Acid, Polysorbate 80, Sucralose, Flavor | Water, Glycerin, Sorbitol, Propylene Glycol, Tetrapotassium Pyrophosphate, PEG-40 Hydrogenated Castor Oil, L-Arginine, PVM/MA Copolymer, Polysorbate 20, Tetrasodium Pyrophosphate, Flavor, Benzyl Alcohol, Sodium Fluoride, Menthol | Glycerin, Water, Dipotassium Oxalate, Flavor, EDTA, Methylparaben, Citric Acid and Saccharin | Rosin, Ethanol, Xylitol, Sodium Fluoride, Hexadecane Phosphate, Citric Acid, Polysorbate 80, Sucralose, Flavor | Calcium Sodium Phosphosilicate, Glycerin, Amorphous Silica, PEG-400, Titanium Dioxide, Sodium Lauryl Sulfate, Flavor, Carbomer, Potassium Acesulfame | Our chemical composition uses a rosin-based formulation for a mechanical occlusion of dentinal tubules, and also includes a novel ingredient to assist in the occlusion, just as the other cleared devices do. |
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1441 Canal Street, New Orleans, Louisiana 70112, United States
| Rennou™ Varnish | Colgate Prevident Varnish | Colgate Desensitizing Mouthwash | Remedent NV Remesense | Ultradent Flor-Opal Varnish | Novamin Oralief Toothpaste | Comments | |
|---|---|---|---|---|---|---|---|
| Technological Characteristics | Provides prolonged contact of ingredients with tooth surface; forms protective barrier; releases minerals to enhance tooth structure. | Provides prolonged contact of ingredients with tooth surface; forms protective barrier; releases minerals to enhance tooth structure. | Provides contact of ingredients with tooth surface; forms protective barrier; releases minerals to enhance tooth structure. | Provides contact of ingredients with tooth surface; forms protective barrier; releases minerals to enhance tooth structure. | Provides prolonged contact of ingredients with tooth surface; forms protective barrier; releases minerals to enhance tooth structure. | Provides contact of ingredients with tooth surface; forms protective barrier; releases minerals to enhance tooth structure. | Technologically, our submitted device has the same characteristics as the primary predicate and other reference devices. |
| Biocompatibility | Yes | Yes | Yes | Yes | Yes | Yes | Any differences between the subject and predicate/reference devices do not raise new safety concerns, as the materials and design are biocompatible and meet established safety standards validated through prior FDA evaluations. |
6. COMPARISON TO PREDICATE DEVICES
The table above summarizes how Rennou™ Varnish is substantially equivalent to the predicate devices in indication for use, product design, composition of material, technological characteristics, and biocompatibility.
7. CONCLUSION
In summary, this submission presents compelling evidence demonstrating that Rennou™ Varnish is substantially equivalent in both safety and effectiveness to its predicate devices. Rigorous testing has shown that Rennou™ Varnish occludes dentinal tubules at a level that meets or exceeds comparable products currently in clinical use. Strict adherence to ISO 10993-5 biocompatibility standards confirms that Rennou™ Varnish is safe when applied as directed by dental professionals.
The technological difference between Rennou™ Varnish and predicate varnishes resides in the formulation. Rennou™ varnish incorporates theobromine and calcium phosphate salts for occlusion benefits. Published scientific literature demonstrates that these ingredients can facilitate mineral deposition on the tooth surface, including the occlusion of dentin tubules. Many predicate cavity varnishes, such as Colgate's Desensitizing Mouthwash with arginine or Novamin's bioglass-containing toothpaste, are similar to the Rennou Varnish in that they contain such ingredients for this purpose.
Critically, this product maintains the established indications for use without introducing any new or unforeseen risks, thus preserving the status quo. The data provided in this submission robustly supports the conclusion that Rennou™ Varnish satisfies all criteria for substantial equivalence, ensuring its safe and effective integration into dental practice.