(2 days)
No
The device description and performance studies focus on the chemical composition and physical properties of a fluoride treatment, with no mention of AI or ML technologies.
Yes
The device is indicated for the "treatment of hypersensitive teeth," which is a therapeutic purpose.
No
Explanation: The "Intended Use / Indications for Use" states that the device is "indicated for the treatment of hypersensitive teeth." This phrasing indicates a therapeutic purpose rather than a diagnostic one. Additionally, the "Device Description" describes it as an "aqueous fluoride coating...applied topically...for the treatment of hypersensitive teeth," further emphasizing its role in treatment, not diagnosis.
No
The device description clearly indicates it is a topical fluoride coating, which is a physical substance applied to teeth, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the treatment of hypersensitive teeth." This is a therapeutic treatment applied directly to the patient's teeth.
- Device Description: The description details a "topical coating" applied to tooth surfaces. This is a physical application to the body.
- Lack of In Vitro Diagnostic Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples from the body.
- Anatomical Site: The anatomical site is "Tooth surfaces," which is a part of the body being treated directly.
The bench testing mentioned focuses on the physical and chemical properties of the coating and its ability to occlude dentin tubules and release fluoride, calcium, and phosphate. These are performance characteristics of the topical treatment itself, not diagnostic tests performed on patient samples.
N/A
Intended Use / Indications for Use
3MIM Clinpro™ Clear 2.1% Sodium Fluoride Treatment is indicated for the treatment of hypersensitive teeth.
Product codes (comma separated list FDA assigned to the subject device)
LBH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth surfaces / teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professional
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)
Physical Properties Bench Studies:
- Dentin tubule occlusion (In-vitro): SEM. Pass/Fail: Must visually occlude (cover) exposed dentin tubules. Results: Pass for Subject, Primary Predicate, and Reference devices.
- 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. Results: Pass for Subject, Primary Predicate, and Reference devices.
- Fluoride Release: ISO 17730-2020. Pass/Fail: Fluoride release potential is ≥ 14 µg F/mm² after 60 minutes. Results: Pass for Subject, Primary Predicate, and Reference devices.
- Fluoride Release: Internal 3M Test Method. Pass/Fail: Cumulative fluoride release potential at 1 hour is >0 µg/cm²/g. Results: Pass for Subject, Primary Predicate, and Reference devices.
- Fluoride Release: Internal 3M Test Method. Pass/Fail: Cumulative fluoride release potential at 24 hours is >0 µg/cm²/g. Results: Pass for Subject, Primary Predicate, and Reference devices.
- Calcium Release: ICP-AES. Pass/Fail: Cumulative calcium release potential at 1 hour is >0 µg/cm²/g. Results: Pass for Subject and Primary Predicate devices. Not tested for Reference.
- Calcium Release: ICP-AES. Pass/Fail: Cumulative fluoride release potential at 24 hours is >0 µg/cm2/g. Results: Pass for Subject and Primary Predicate devices. Not tested for Reference.
- Phosphorus (Phosphate) Release: ICP-AES. Pass/Fail: Cumulative phosphorus (phosphate) release potential at 1 hour is >0 µg/cm2/g. Results: Pass for Subject, Primary Predicate, and Reference devices.
- Phosphorus (Phosphate) Release: ICP-AES. Pass/Fail: Cumulative phosphorus (phosphate) release potential at 24 hours is >0 µg/cm2/g. Results: Pass for Subject, Primary Predicate, and Reference devices.
- Consistency: Internal 3M Test Method. Pass/Fail: The reading number of 1/32th inch is 32-52. Results: Pass for Subject and Primary Predicate devices. Not applicable for Reference.
- pH: Internal 3M Test Method. Pass/Fail: 6.0-8.0. Results: Pass for Subject and Reference devices. Not applicable for Primary Predicate.
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.
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.
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.
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
§ 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.
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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.
1
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
2
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 Products
2510 Conway Avenue
St. Paul, MN 55144, USA
Establishment Registration No.: 3005174370 |
|------------------|------------------------------------------------------------------------------------------------------------------------|
| Primary Contact | Chandrapaul Parsram, M.S.
Regulatory Affairs Associate
Phone: (651) 467 3014
cparsram@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 Products
2510 Conway Avenue
Saint Paul, MN, 55144 | IVOCLAR VIVADENT AG
175 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 Cavity | |||
| varnish | 21 CFR.872.3260 Cavity | |||
| varnish | 21 CFR.872.3260 Cavity | |||
| varnish | Identical | |||
| Intended Use per | ||||
| Regulation | Fluoridated tooth coating. | Fluoridated tooth coating. | Fluoridated tooth coating. | Identical |
| Indications for | ||||
| Use - 510(k) | Clinpro Clear 2.1% Sodium | |||
| Fluoride Treatment is | ||||
| indicated for the treatment of | ||||
| hypersensitive teeth. | •Treatment of hypersensitive | |||
| teeth | ||||
| • Use on exposed dentin and | ||||
| root sensitivity | ||||
| • Under temporary | ||||
| restoratives and cements | ||||
| where post-operative | ||||
| sensitivity is of concern | •Treatment of dentinal | |||
| hypersensitivity | ||||
| •Treatment of exposed | ||||
| cervical | ||||
| •Treatment of sensitivity | ||||
| after tooth whitening | All three devices are indicated for use | |||
| in the treatment of hypersensitive teeth. | ||||
| Both the subject device and primary | ||||
| predicate device are indicated for use in | ||||
| the treatment of hypersensitive teeth. | ||||
| Fluor Protector S also has the same | ||||
| indication, expressed as dentinal | ||||
| hypersensitivity. | ||||
| Contraindication | None known. | Ulcerative gingivitis and | ||
| stomatitis | If patients are known to be | |||
| allergic to any of the | ||||
| ingredients of | ||||
| Fluor Protector S, the | ||||
| material should not be used. | Different – Subject device is not | |||
| contraindicated for use in patients with | ||||
| ulcerative gingivitis and stomatitis | ||||
| because it is not formulated with a | ||||
| colophony polymer. The subject device | ||||
| does not have any known | ||||
| contraindications. | ||||
| 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 technological | |||
| characteristics 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 in | |||
| Sachet | Single-use, unit-amount | |||
| ampoule | ||||
| Multi-use, multi-unit tube | Same | |||
| Applicator | Disposable brush applicator | Disposable brush applicator | Disposable brush applicator | Same |
| Fluoride | ||||
| Compound, | ||||
| Amount | Sodium fluoride (NaF), 2.1% | |||
| (wt/wt) | Sodium fluoride (NaF), 5% | |||
| (wt/wt) | Ammonium fluoride | |||
| (NH4F), 1.5% (wt/wt) | Different; however, different questions | |||
| of safety or effectiveness are not raised | ||||
| because significant concerns are not | ||||
| raised. | ||||
| Amount of | ||||
| fluoride Ion | 9,500 ppm | 22,500 ppm | 7,700 ppm | The amount of fluoride ions |
| between the subject and reference device | ||||
| is similar. | ||||
| Releases | ||||
| Fluoride | Yes | Yes | Yes | Same |
| Releases | ||||
| Phosphate | Yes | Yes | Not designed to release | |
| phosphate | Same | |||
| Releases | ||||
| Calcium | Yes | Yes | Not designed to release | |
| calcium | Same | |||
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Shelf Life | 24 months | 24 months | Unknown | Same |
| Materials | Polyacrylic acid, hydroxyethyl | |||
| cellulose, calcium salt, | ||||
| phosphate salt, pH buffer, | ||||
| flavor, sodium fluoride, water, | ||||
| xylitol, potassium sorbate | colophony resin, n-hexane, | |||
| ethyl, alcohol, sodium | ||||
| fluoride, food grade flavor, | ||||
| flavor enhancer, thickener, | ||||
| modified tricalcium | ||||
| phosphate | Ethanol/water, polymer, | |||
| additive, ammonium | ||||
| fluoride, saccharin, mint | ||||
| aroma | Different; however, different questions | |||
| of safety or effectiveness are not raised | ||||
| because significant concerns are not | ||||
| raised. 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. |
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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 | |||||
|---|---|---|---|---|---|
| Physical | |||||
| Properties | Test Method | Specification | 3M Clinpro | ||
| Clear 2.1% | |||||
| Sodium Fluoride | |||||
| Treatment | |||||
| (Subject Device) | 3M Vanish Varnish | ||||
| (Primary Predicate, | |||||
| K092141) | Fluor Protector | ||||
| S (Reference, | |||||
| K131487) | |||||
| 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 | ||
| Internal 3M | |||||
| Test Method | Pass/Fail: Cumulative fluoride release potential | ||||
| at 1 hour is >0 µg/cm²/g | Pass | Pass | Pass | ||
| Pass/Fail: Cumulative fluoride release potential | |||||
| at 24 hours is >0 µg/cm²/g | Pass | Pass | Pass | ||
| Calcium Release | ICP-AES | Pass/Fail: Cumulative calcium release potential | |||
| at 1 hour is >0 µg/cm²/g | Pass | Pass | Not tested - not | ||
| claimed by the | |||||
| manufacturer. | |||||
| Pass/Fail: Cumulative fluoride release potential | |||||
| at 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 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 |
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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