(2 days)
3MIM Clinpro™ Clear 2.1% Sodium Fluoride Treatment is indicated for the treatment of hypersensitive teeth.
3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment is an aqueous fluoride coating that is applied topically to the tooth surfaces for the treatment of hypersensitive teeth. The product is sweetened with xylitol and sucralose. Clinpro 2.1% Sodium Fluoride Treatment contains 9,500 ppm fluoride and added calcium and phosphate. 3M Clinpro Clear 2.1% Sodium Fluoride Treatment uses the L-Pop™ unit dose dispensing system designed by 3M. Each L-Pop contains 0.5 ml (0.5 grams) of the coating and is offered in mint and melon flavors and a flavorless version.
The provided document is a 510(k) premarket notification for a medical device called "3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a full clinical trial to prove efficacy and safety through detailed acceptance criteria and studies as one might see for novel high-risk devices.
Therefore, the information typically available for a detailed acceptance criteria and performance study (as requested in the prompt) such as prospective studies, ground truth establishment by multiple experts with adjudication, MRMC studies, or standalone algorithm performance, is not present in this type of FDA submission.
Instead, the document details bench testing to demonstrate that the subject device performs similarly to or better than its predicate devices based on certain physical properties and release characteristics. The acceptance criteria here are mainly "Pass/Fail" based on whether the device meets specific thresholds or shows comparable performance to the predicate devices in these bench tests.
Here's an attempt to extract and present the available information in the requested format, with the understanding that many aspects of your request (e.g., human-in-the-loop studies, multi-reader studies, detailed expert ground truth, training set information) are not applicable or not provided in a 510(k) submission for a dental varnish.
Acceptance Criteria and Device Performance Study for 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
Note: This 510(k) submission primarily relies on demonstrating substantial equivalence through bench testing against predicate devices, rather than clinical efficacy studies with human subjects. Therefore, many of the requested details, particularly those related to human reader studies, multi-expert ground truth establishment, and training/test set specifics for AI/ML models, are not applicable or not provided in this type of regulatory document for a tooth varnish. The "acceptance criteria" here refer to the performance thresholds set for the bench tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Physical Properties/Characteristic | Test Method | Acceptance Criteria (Specification) | Reported Device Performance (3M Clinpro Clear 2.1% Sodium Fluoride Treatment) | Predicate Device (3M Vanish Varnish) Performance | Reference Device (Fluor Protector S) Performance |
|---|---|---|---|---|---|
| Dentin tubule occlusion (In-vitro) | SEM | Pass/Fail: Must visually occlude (cover) exposed dentin tubules | Pass | Pass | Pass |
| Dentin fluid flow reduction (In-vitro) | Modified Pashley Test | Pass/Fail: Must demonstrate visual reduction in fluid flow when treated compared to when they were untreated | Pass | Pass | Pass |
| Fluoride Release | ISO 17730-2020 | Pass/Fail: Fluoride release potential is ≥ 14 µg F/mm² after 60 minutes | Pass | Pass | Pass |
| Cumulative fluoride release potential (1 hour) | Internal 3M Test Method | Pass/Fail: Cumulative fluoride release potential at 1 hour is >0 µg/cm²/g | Pass | Pass | Pass |
| Cumulative fluoride release potential (24 hours) | Internal 3M Test Method | Pass/Fail: Cumulative fluoride release potential at 24 hours is >0 µg/cm²/g | Pass | Pass | Pass |
| Calcium Release (1 hour) | ICP-AES | Pass/Fail: Cumulative calcium release potential at 1 hour is >0 µg/cm²/g | Pass | Pass | Not tested - not claimed |
| Calcium Release (24 hours) | ICP-AES | Pass/Fail: Cumulative fluoride release potential at 24 hours is >0 µg/cm2/g | Pass | Pass | Not tested - not claimed |
| Phosphorus (Phosphate) Release (1 hour) | ICP-AES | Pass/Fail: Cumulative phosphorus (phosphate) release potential at 1 hour is >0 µg/cm2/g | Pass | Pass | Pass |
| Phosphorus (Phosphate) Release (24 hours) | ICP-AES | Pass/Fail: Cumulative phosphorus (phosphate) release potential at 24 hours is >0 µg/cm2/g | Pass | Pass | Pass |
| Consistency | Internal 3M Test Method | Pass/Fail: The reading number of 1/32th inch is 32-52. | Pass | Pass | Not applicable (3M requirement) |
| pH | Internal 3M Test Method | Pass/Fail: 6.0-8.0 | Pass | Not applicable | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or clinical images, as the evaluation is based on in-vitro bench testing of the device material. The sample size for each bench test (e.g., number of replicates, number of specimens) is typically detailed in the internal test reports, but not provided in this summary. The data provenance is from laboratory bench testing conducted by 3M, not from specific patient populations or countries.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The "ground truth" for this device's performance is established by standardized laboratory testing methods and physical measurements, not by human expert interpretation of clinical data or images.
4. Adjudication Method for the Test Set
Not applicable. As the "test set" is material performance data from laboratory tests, no adjudication method is required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study (comparing human readers with and without AI assistance) is not applicable to a dental varnish product. This device is not an imaging AI or diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product (dental varnish), not an algorithm or software. Its performance is evaluated through material science and physical property tests.
7. The Type of Ground Truth Used
The ground truth used is based on physical and chemical measurements and observations from in-vitro laboratory bench tests, conforming to established standards (e.g., ISO 17730-2020) or validated internal methods. For example, "visually occlude exposed dentin tubules" for SEM, or measurable fluoride release values.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not a machine learning model, so there is no "training set" in the context of data for model development.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 10, 2023
3M ESPE Dental Products % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K231338
Trade/Device Name: 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity varnish Regulatory Class: Class II Product Code: LBH Dated: May 8, 2023 Received: May 8, 2023
Dear Prithul Bom:
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231338
Device Name
3MTM Clinpro™ Clear 2.1% Sodium Fluoride Treatment
Indications for Use (Describe)
3MIM Clinpro™ Clear 2.1% Sodium Fluoride Treatment is indicated for the treatment of hypersensitive teeth.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the 3M logo, which consists of the number "3" and the letter "M" in a bold, sans-serif font. The logo is colored in red and is set against a white background. The logo is simple and recognizable, representing the multinational conglomerate 3M Company.
This 510(k) summary is submitted in accordance with the requirements of 21 CFR §807.92
Submitter Information
| 510(k) Submitter | 3M ESPE Dental Products2510 Conway AvenueSt. Paul, MN 55144, USAEstablishment Registration No.: 3005174370 |
|---|---|
| Primary Contact | Chandrapaul Parsram, M.S.Regulatory Affairs AssociatePhone: (651) 467 3014cparsram@mmm.com |
| Submission Date | April 28th, 2023 |
Subject Device Information
| Proprietary Trade Name | 3M™ Clinpro™ |
|---|---|
| Device Name | 2.1% Sodium Fluoride Treatment |
| Common Name | Cavity varnish |
| Classification Name | Cavity varnish |
| Regulation Number | 21 CFR § 872.3260 |
| Product Code | LBH |
| Classification Panel | Dental Products |
| Classification | Medical Device, Class II |
Predicate and Reference Devices:
| Product Name | 3M Vanish Varnish(Primary Predicate) | Fluor Protector S(Reference) |
|---|---|---|
| Manufacturer | 3M ESPE Dental Products2510 Conway AvenueSaint Paul, MN, 55144 | IVOCLAR VIVADENT AG175 PINEVIEW DR.AMHERST, NY 14228 |
| 510(k) Number | K092141 | K131487 |
| Device Class | 2 - LBH (Cavity varnish) | 2 - LBH (Cavity varnish) |
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Image /page/4/Picture/0 description: The image shows the 3M logo. The logo is red and consists of the number "3" followed by the letter "M". The logo is simple and recognizable. The color red is bold and eye-catching.
Description of Device
3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment is an aqueous fluoride coating that is applied topically to the tooth surfaces for the treatment of hypersensitive teeth. The product is sweetened with xylitol and sucralose. Clinpro 2.1% Sodium Fluoride Treatment contains 9,500 ppm fluoride and added calcium and phosphate. 3M Clinpro Clear 2.1% Sodium Fluoride Treatment uses the L-Pop™ unit dose dispensing system designed by 3M. Each L-Pop contains 0.5 ml (0.5 grams) of the coating and is offered in mint and melon flavors and a flavorless version.
Indications for Use
3M Clinpro Clear 2.1% Sodium Fluoride Treatment is indicated for the treatment of hypersensitive teeth.
Substantial Equivalence
Substantial equivalency of 3M Clinpro Clear 2.1% Sodium Fluoride Treatment (subject device) to 3M™ Vanish (primary predicate) and Fluor Protector S (reference) is made on the basis of intended/indicated use, technological characteristics, and performance testing according to the Agency's Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] dated July 28, 2014.
| Substantial Equivalence - Intended/Indicated Use | ||||
|---|---|---|---|---|
| Device | 3M Clinpro Clear 2.1%Sodium Fluoride Treatment(Subject Device) | 3M Vanish Varnish(Primary Predicate,K092141) | Fluor Protector S(Reference, K131487) | Comparison |
| Product Code | LBH | LBH | LBH | Identical |
| Regulation | 21 CFR.872.3260 Cavityvarnish | 21 CFR.872.3260 Cavityvarnish | 21 CFR.872.3260 Cavityvarnish | Identical |
| Intended Use perRegulation | Fluoridated tooth coating. | Fluoridated tooth coating. | Fluoridated tooth coating. | Identical |
| Indications forUse - 510(k) | Clinpro Clear 2.1% SodiumFluoride Treatment isindicated for the treatment ofhypersensitive teeth. | •Treatment of hypersensitiveteeth• Use on exposed dentin androot sensitivity• Under temporaryrestoratives and cementswhere post-operativesensitivity is of concern | •Treatment of dentinalhypersensitivity•Treatment of exposedcervical•Treatment of sensitivityafter tooth whitening | All three devices are indicated for usein the treatment of hypersensitive teeth.Both the subject device and primarypredicate device are indicated for use inthe treatment of hypersensitive teeth.Fluor Protector S also has the sameindication, expressed as dentinalhypersensitivity. |
| Contraindication | None known. | Ulcerative gingivitis andstomatitis | If patients are known to beallergic to any of theingredients ofFluor Protector S, thematerial should not be used. | Different – Subject device is notcontraindicated for use in patients withulcerative gingivitis and stomatitisbecause it is not formulated with acolophony polymer. The subject devicedoes not have any knowncontraindications. |
| Intended User | Dental professional | Dental professional | Dental professional | Identical |
| Substantial Equivalency – Technological Characteristics | ||||
|---|---|---|---|---|
| Device | 3M Clinpro Clear 2.1%Sodium Fluoride Treatment(Subject Device) | 3M Vanish Varnish(Primary Predicate,K092141) | Fluor Protector S(Reference, K131487 ) | Comparison - Are the technologicalcharacteristics different? |
| Mode of Action | Dentin Tubule Occlusion | Dentin Tubule Occlusion | Dentin Tubule Occlusion | Same |
| Dispensing Form | Single-use, unit-amount in L-Pop | Single-use, unit-amount inSachet | Single-use, unit-amountampouleMulti-use, multi-unit tube | Same |
| Applicator | Disposable brush applicator | Disposable brush applicator | Disposable brush applicator | Same |
| FluorideCompound,Amount | Sodium fluoride (NaF), 2.1%(wt/wt) | Sodium fluoride (NaF), 5%(wt/wt) | Ammonium fluoride(NH4F), 1.5% (wt/wt) | Different; however, different questionsof safety or effectiveness are not raisedbecause significant concerns are notraised. |
| Amount offluoride Ion | 9,500 ppm | 22,500 ppm | 7,700 ppm | The amount of fluoride ionsbetween the subject and reference deviceis similar. |
| ReleasesFluoride | Yes | Yes | Yes | Same |
| ReleasesPhosphate | Yes | Yes | Not designed to releasephosphate | Same |
| ReleasesCalcium | Yes | Yes | Not designed to releasecalcium | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Shelf Life | 24 months | 24 months | Unknown | Same |
| Materials | Polyacrylic acid, hydroxyethylcellulose, calcium salt,phosphate salt, pH buffer,flavor, sodium fluoride, water,xylitol, potassium sorbate | colophony resin, n-hexane,ethyl, alcohol, sodiumfluoride, food grade flavor,flavor enhancer, thickener,modified tricalciumphosphate | Ethanol/water, polymer,additive, ammoniumfluoride, saccharin, mintaroma | Different; however, different questionsof safety or effectiveness are not raisedbecause significant concerns are notraised. The essential design of theseproducts is the same. All three productsare formulated with a polymer that coatsthe teeth, a fluoride mineral, a solvent todissolve the fluoride mineral, andadditives such as flavoring agents andrheology modifiers. |
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Image /page/5/Picture/0 description: The image shows the 3M logo, which consists of the number "3" and the letter "M" in a bold, sans-serif font. The logo is colored in red and is set against a white background. The logo is simple and recognizable, representing the multinational conglomerate 3M Company.
| Substantial Equivalency – Performance Bench Studies | |||||
|---|---|---|---|---|---|
| PhysicalProperties | Test Method | Specification | 3M ClinproClear 2.1%Sodium FluorideTreatment(Subject Device) | 3M Vanish Varnish(Primary Predicate,K092141) | Fluor ProtectorS (Reference,K131487) |
| Dentin tubuleocclusion (In-vitro) | SEM | Pass/Fail: Must visually occlude (cover)exposed dentin tubules | Pass | Pass | Pass |
| Dentin fluid flowreduction (In-vitro) | ModifiedPashley Test | Pass/Fail: Must demonstrate visual reduction influid flow when treated compared to when theywere untreated | Pass | Pass | Pass |
| Fluoride Release | ISO 17730-2020 | Pass/Fail: Fluoride release potential is ≥ 14 µgF/mm² after 60 minutes | Pass | Pass | Pass |
| Internal 3MTest Method | Pass/Fail: Cumulative fluoride release potentialat 1 hour is >0 µg/cm²/g | Pass | Pass | Pass | |
| Pass/Fail: Cumulative fluoride release potentialat 24 hours is >0 µg/cm²/g | Pass | Pass | Pass | ||
| Calcium Release | ICP-AES | Pass/Fail: Cumulative calcium release potentialat 1 hour is >0 µg/cm²/g | Pass | Pass | Not tested - notclaimed by themanufacturer. |
| Pass/Fail: Cumulative fluoride release potentialat 24 hours is >0 µg/cm2/g | Pass | Pass | |||
| Phosphorus(Phosphate) Release | ICP-AES | Pass/Fail: Cumulative phosphorus (phosphate)release potential at 1 hour is >0 µg/cm2/g | Pass | Pass | Pass |
| Pass/Fail: Cumulative phosphorus (phosphate)release potential at 24 hours is >0 µg/cm2/g | Pass | Pass | |||
| Consistency | Internal 3MTest Method | Pass/Fail: The reading number of 1/32th inch is32-52. | Pass | Pass | Not applicable.3M requirement. |
| pH | Internal 3MTest Method | Pass/Fail: 6.0-8.0 | Pass | Not applicable. | Pass |
Biocompatibility Assessment
A Diplomate of the American Board of Toxicology has assessed this product's safety and determined that it is safe for its intended use. 3M Clinpro Clear 2.1% Sodium Fluoride Treatment was assessed as a surface in contact with mucosal membrane for less than or equal to 24 hours (ISO 10993, ISO 7405. FDA-2013-D-0350, and PFSB). In accordance with the combined guidance found in ISO 10993, ISO 7405, Testing guidelines outlined in the US FDA Docket Number FDA-2013-D-0350, and Japan: PSEHB/MDED No. 0106-1 and 0612-4, the following endpoints must be considered in the biocompatibility evaluation of this product: Physical and/or Chemical Information, Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity. In addition, Acute Systemic Toxicity and Pulp/Dentin effects were assessed.
Conclusion
3M Clinpro Clear 2.1% Sodium Fluoride Treatment has the same intended use as 3M Vanish Vamish and Fluor Protector S. In addition, all three devices are in the treatment of hypersensitive teeth. 3M Clinpro Clear 2.1% Sodium Fluoride Treatment has similar but not identical technological characteristics to the predicate device. Minor differences in the technological characteristics include a difference in the amount of fluoride and material formulations. These different questions of safety of effectiveness because significant concerns about safety or effectiveness are not raised for the subject device. Bench testing was conducted to compare the performance of 3M Clinpro Clear 2.1% Sodium Fluoride Treatment to 3M Vanish and Fluor Protector S. In addition, biocompatibility studies were completed. All testing demonstrates the safety and performance of 3M Cliniro Clear 2.1% Sodium Fluoride Treatment are substantially equivalent to the predicate device.
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§ 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.