(438 days)
Treatment of Dental Hypersensitivity for use in adults over the age of 21.
The Centrix FluoroSilver is a professional tooth desensitizer that is composed of Aqueous Silver Diamine Fluoride, 38.3% to 43.2% w/v. The solution is composed of water, ammonia, fluoride, silver and a colorant. The device is provided in a single 5 ml squeezable dropper bottle or a multi-pack which includes three 5 ml squeezable dropper bottles. Each variation is packaged in a preformed trav and includes applicators and the Instructions for Use (IFU). The primary mode of action is to reduce dentinal hypersensitivity by occluding open dentin tubules by the formation of a precipitate.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device (Centrix FluoroSilver Silver Diamine Fluoride 38%). This type of document is provided when a company seeks to demonstrate that their new device is substantially equivalent to a legally marketed predicate device. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to demonstrating substantial equivalence through various performance and material characteristic comparisons, rather than clinical efficacy trials with predefined clinical acceptance criteria as would be typical for a PMA.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are implicitly defined by the characteristics of the predicate device and relevant standards. The goal is to show the new device is "substantially equivalent."
| Characteristic / Parameter | Implicit "Acceptance Criteria" (Predicate Device Performance/Standard) | Reported Device Performance (Centrix FluoroSilver) | Discussion / Substantial Equivalence |
|---|---|---|---|
| Primary Mode of Action | Reduce dentinal hypersensitivity by occluding open dentin tubules by formation of a precipitate. | Reduce dentinal hypersensitivity by occluding open dentin tubules by formation of a precipitate. | Identical |
| Indications for Use | Treatment of dentinal hypersensitivity for use in adults over the age of 21. | Treatment of Dental Hypersensitivity for use in adults over the age of 21. | Identical |
| SDF Concentration (w/v) | 38.3% to 43.2% (of predicate, based on general description) | 38.3% to 43.2% w/v (stated in device description) | Identical range. The comparison table states 38% for both. |
| Silver Diamine Fluoride (SDF) | 360 - 400 g/L (as per predicate's typical specifications) | 360 - 400 g/L | Specifications match. |
| Fluoride | 50 - 60 g/L | 50 - 60 g/L | Specifications match. |
| pH | 8.5 - 9.5 | 8.5 - 9.5 | Specifications match. |
| Density | 1.265 - 1.276 g/L | 1.265 - 1.276 g/L | Specifications match. |
| Cytotoxicity (ISO 10993-5) | Positive cytotoxicity (predicate device) | "Unsuitable for analysis" due to high precipitate, and performed identically to predicate. | Both devices showed positive cytotoxicity when tested, and their performance was identical ("unsuitable for analysis" due to precipitate formation). This is considered equivalent for the purpose of demonstrating safety profile similarity, given the context of a dentin desensitizer that causes precipitation. |
| Skin Sensitization (ISO 10993-10) | Not considered a contact skin sensitizer (presumably the predicate also meets this) | NOT considered to be a contact skin sensitizer. | Acceptable and considered safe. There is no explicit statement about the predicate's performance on this specific test, but the conclusion for the subject device is a positive safety finding. |
| Irritation (ISO 10993-23) | Non-Irritant to oral mucosa (presumably the predicate also meets this) | Non-Irritant to oral mucosa. | Acceptable and considered safe. Similar to skin sensitization, this is a positive safety finding. |
| Acute Systemic Toxicity (ISO 10993-11) | No signs of gross toxicity, adverse clinical effects, or abnormal behavior (predicate device) | No signs of gross toxicity, adverse clinical effects, or abnormal behavior. No gross abnormalities noted after 3 day observation and necropsy. Performed identically to predicate. | Identical performance with the predicate. Both met requirements. |
| SEM Analysis | No discernible difference in silver deposition (predicate expected to have robust deposition) | Silver deposition on dentin and in tubules between Centrix SDF and Elevate SDF showed no discernible difference based on SEM analyses. Significant deposits of silver on cut surface of tooth and within dentinal tubules. | Identical. Confirms similar physical mechanism of action (tubule occlusion). |
| Fluoride Release | 0.024 +/- 0.006 ppmF/mm² (predicate device) | 0.023 +/- 0.003 ppmF/mm² | Identical. No statistical difference confirmed equivalent fluoride release. |
| Dentin Permeability Reduction | 97.5% +/- 2.5% (predicate device) | 97.5% +/- 4.3% | Identical. Both devices reduced dentin permeability by an average of 97.5%. This is a key functional performance criterion directly related to the indication for use. |
| Chemical Composition Profile | Nearly Identical (predicate device) | Strong match between subject and predicate device via MS analysis for chemical composition. | Nearly identical. Confirmed by Mass Spectrometry. Differences in colorant (Fast Green FCF Dye vs. FD&C Blue 1) are noted but considered minor and not impacting substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the sense of a clinical trial for performance. Instead, it describes various laboratory and in vitro/in vivo (animal) studies for substantial equivalence.
- Cytotoxicity (ISO 10993-5): No specific sample size mentioned, likely standardized by the ISO method.
- Skin Sensitization (ISO 10993-10): No specific sample size mentioned, likely standardized by the ISO method (typically animal models).
- Irritation (ISO 10993-23): No specific sample size mentioned, likely standardized by the ISO method (typically animal models for oral mucosa).
- Acute Systemic Toxicity (ISO 10993-11): No specific sample size mentioned, likely standardized by the ISO method (typically animal models like rats or mice).
- SEM Analysis: "Human tooth samples" used. Number not specified.
- Fluoride Release Testing: "SDF treated tooth cross sections" used. Number not specified.
- Dentin Permeability: "Human molar teeth samples" used. Number not specified, but the results include standard deviations, implying a sample size greater than one.
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given that these are bench and preclinical studies for a 510(k), they are generally prospective laboratory studies. "Human molar teeth samples" would typically be ethically sourced from dental extractions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is generally not applicable to a 510(k) submission for substantial equivalence based on bench/preclinical testing. There is no "ground truth" established by experts in the context of interpreting images or clinical outcomes data. The "ground truth" for the tests mentioned (e.g., cytotoxicity, fluoride release, dentin permeability) is determined by the objective measurements and protocols of the respective ISO standards or laboratory methodologies.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human readers or expert consensus on qualitative data (e.g., image interpretation, clinical diagnosis). The studies presented are objective, quantitative laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses the performance of human readers, typically in interpreting medical images, with and without AI assistance. The device in question (Centrix FluoroSilver Silver Diamine Fluoride 38%) is a chemical product for treating dental hypersensitivity, not an imaging or diagnostic AI device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a chemical substance, not a software algorithm or an AI device. The term "standalone performance" for an algorithm does not apply here. The performance of the substance itself was evaluated.
7. The Type of Ground Truth Used
The "ground truth" used for these substantial equivalence tests were objective, quantitative measurements and observations derived from standardized laboratory tests:
- Cytotoxicity: Observation of cellular response in vitro according to ISO 10993-5.
- Skin Sensitization: Dermal response in animal models according to ISO 10993-10.
- Irritation: Mucosal response in animal models according to ISO 10993-23.
- Acute Systemic Toxicity: Clinical observations and necropsy findings in animal models according to ISO 10993-11.
- SEM Analysis: Direct microscopic observation of silver deposition on tooth samples.
- Fluoride Release Testing: Quantitative measurement of fluoride concentration.
- Dentin Permeability: Quantitative measurement of water flow through dentin.
- Chemical Identity Testing: Mass Spectrometry data for chemical composition.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device where a "training set" would be used to develop an algorithm. The device is a chemical product.
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reason as above.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
October 27, 2023
Centrix Inc % Joseph Azary Chief Advisor & Compliance Officer Aztech Regulatory & Quality LLC 543 Long Hill Avenue Shelton, Connecticut 06484
Re: K222459
Trade/Device Name: Centrix FluoroSilver Silver Diamine Fluoride 38% Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity varnish Regulatory Class: Class II Product Code: PHR Dated: August 12, 2022 Received: August 15, 2022
Dear Joseph Azary:
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.
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).
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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 OS 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 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-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 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.
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-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,
Bobak Shirmohammadi -2
For Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
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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) K222459
Device Name
Centrix FluoroSilver Silver Diamine Fluoride 38%
Indications for Use (Describe) Treatment of Dental Hypersensitivity for use in adults over the age of 21.
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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K222459 510(k) Summary CENTRIX FLUOROSILVER SILVER DIAMINE FLUORIDE 38%
SUBMITTER/510(K) HOLDER 1.
Centrix Inc 770 River Road Shelton, CT 06484
Contact Name: Joseph Azary (Aztech Regulatory & Quality LLC) Email: jazary@erols.com Telephone: (203) 242-6670
Date Prepared: October 26, 2023
DEVICE NAME 2.
| Proprietary Name: | Centrix FluoroSilver Silver Diamine Fluoride 38% |
|---|---|
| Common/Usual Name: | Tooth Desensitizer |
| Classification Name: | Tooth Desensitizer |
| Classification Regulation: | 21 CFR 872.3260 |
| Product code: | PHR |
| Classification: | Class 2 |
| Medical Specialty (Panel): | Division of Dental and ENT devices |
3. PREDICATE DEVICES
- . Advantage Arrest (Elevate Oral Care aka ADP Silver Dental Arrest) K102973
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4. DEVICE DESCRIPTION
The Centrix FluoroSilver is a professional tooth desensitizer that is composed of Aqueous Silver Diamine Fluoride, 38.3% to 43.2% w/v. The solution is composed of water, ammonia, fluoride, silver and a colorant.
The device is provided in a single 5 ml squeezable dropper bottle or a multi-pack which includes three 5 ml squeezable dropper bottles. Each variation is packaged in a preformed trav and includes applicators (more information provided below) and the Instructions for Use (IFU).
The primary mode of action is to reduce dentinal hypersensitivity by occluding open dentin tubules by the formation of a precipitate.
The dentist must clean and dry the affected tooth surface and then dispense 1-2 drops of solution into a disposable dappen dish. The material is applied directly to the tooth surface using Centrix supplied applicators (Centrix Benda Micro Fine Brushes). The tooth must be allowed to air dry and then if needed one or two reapplications can be administered at intervals of one week.
The packaging will labeled with lot number, expiration date and UDI barcode. The shelf life of the device is 24 months.
The device is packaged with applicators (Centrix Benda Micro Fine Brushes) that are classified as class I 510(k) exempt medical devices under regulation 21 CFR 872.3140, Product Code KXR. A quantity of applicators will be provided in a zip lock bag.
The primary mode of action is to reduce dentinal hypersensitivity by occluding open dentin tubules by the formation of a precipitate.
| Parameter | Specification |
|---|---|
| Silver Diamine Fluoride (SDF) | 360 - 400 g/L |
| Fluoride | 50 - 60 g/L |
| pH | 8.5 - 9.5 |
| Density | 1.265 - 1.276 g/L |
Specifications
5. INDICATIONS FOR USE
Treatment of Dental Hypersensitivity for use in adults over the age of 21.
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6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The solution is applied to the tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity. The solution precipitates upon application resulting in a physical blockage of dentinal tubules.
The subject device has equivalent indications for use, technical characteristics, mode of action, material composition (confirmed through chemical identity testing), SDF % and cytotoxicity results (comparative cytotoxicity testing) when compared to the selected predicate device.
Additionally, the subject device has a different colorant, uses different size bottles, and some minor differences in wording in labeling. These differences are minor and the overall similarities support the equivalence between the subject and predicate device.
| CentrixFluoroSilverSilver DiamineFluoride 38% | Advantage Arrest | Discussion | |
|---|---|---|---|
| 510(k) Number | K222459 | K102973 | |
| Company | Centrix Inc | Elevate Oral Care(named as ADPSilver Dental ArrestLLC in 510k) | |
| Classification Name | Cavity Varnish | Cavity Varnish | IDENTICAL |
| Common Name | Tooth Desensitizer | Tooth Desensitizer | IDENTICAL |
| Regulation Number | 872.3260 | 872.3260 | IDENTICAL |
| Product Code | PHR | PHR | IDENTICAL |
| Indications for Use | Treatment of DentalHypersensitivity foruse in adults over theage of 21. | Treatment of dentinalhypersensitivity.For use in adult overthe age of 21. | IDENTICAL |
| Technical Method / Characteristics | Silver diaminefluoride formsprecipitates withcalcium or phosphatein the dentinaltubules to block opendentinal tubules. | Silver diaminefluoride formsprecipitates withcalcium or phosphatein the dentinaltubules to block opendentinal tubules. | IDENTICAL |
| Mode of Action | Tubule occlusion | Tubule occlusion | IDENTICAL |
| Material Composition | Silver diaminefluoridePurified Water | Silver diaminefluoridePurified Water | IDENTICAL |
Comparison Table
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| Fast Green FCF DyeHPLC – Mass Spec | FD&C Blue 1HPLC Mass Spec | ||
|---|---|---|---|
| ChemicalComposition Profile | Nearly Identical- CompositionalEquivalency | ||
| Color | Green | Blue / Violet | IDENTICAL |
| % SDF | 38% | 38% | IDENTICAL |
| Application | Liquid | Liquid | IDENTICAL |
| Rx / OTC | Rx | Rx | IDENTICAL |
| Packaging | Squeezable DropperBottle5 ml bottleThree 5ml bottle kitApplicator(s) | Squeezable DropperBottle8ml bottleThree 3ml bottle kit | IDENTICALPackaging typeDifferent Sizebottles |
| Cytotoxicity | Yielded positivecytotoxicity whentested to ISO 10993-5 | Yielded positivecytotoxicity whentested to ISO 10993-5 | IDENTICAL |
| Fluoride Release | 0.023 +/- 0.003ppmF/mm² | 0.024 +/- 0.006ppmF/mm² | IDENTICALNo statisticaldifferencebetweendevices. |
| SEM Analysis | Silver deposition on dentin and in tubulesbetween Centrix SDF and Elevate SDFshowed no discernable difference based onSEM analyses. | IDENTICALNo discernabledifferencebetweendevices. | |
| Dentin Permeability | Dentin Permeability. Human molar teethsamples were evaluated to calculate the %reduction of dentin permeability using theratio of average treated volume of waterpassing through the dentin divided by theaverage baseline rate of flow.The results found that tooth samples treatedwith the subject and predicate device reducedthe dentin permeability by an average 97.5%.Dentin permeability is thought to be related todentin sensitivity. Treatments that reducedentin permeability have been found to stoppain due to dentin sensitivity.Centrix % Reduction in Dentin Permeability97.5% +/- 4.3%Elevate % Reduction in Dentin Permeability97.5% +/- 2.5% | IDENTICAL |
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7. PERFORMANCE TESTING
The following standards were either used as a reference and/or for testing of the subject device:
| Summary of Testing | ||
|---|---|---|
| Standard | Description of Test | Results |
| ISO 10993-5 (2009)Cytotoxicity | Biological Evaluation of MedicalDevices – Part 5: Tests for in vitrocytotoxicity | Cytotoxicity testing was conducted on boththe subject (Centrix) and predicate (Elevate)devices. The testing found both the subjectdevice and predicate device samples were"unsuitable for analysis" due to the highlevel of precipitate generated when the testarticles were combined with culture media.The subject device performed identically tothe predicate device. |
| ISO 10993-10 (2021) | Biological Evaluation of MedicalDevices - Part 10: Tests for SkinSensitization | The testing concluded that the subjectdevice is NOT considered to be a contactskin sensitizer. |
| ISO 10993-23 (2021) | Biological Evaluation of MedicalDevices – Part 23: Tests for Irritation | The testing concluded that the subjectdevice is considered to be a Non-Irritant tooral mucosa. |
| ISO 10993-11 (2017) | Biological Evaluation of MedicalDevices – Part 11: Tests for SystemicToxicity | Acute Systemic Toxicity testing wasconducted on both the subject device(Centrix) and Predicate Device (Elevate).The testing concluded that there were nosigns of gross toxicity, adverse clinicaleffects, or abnormal behavior. No grossabnormalities were noted after a 3 dayobservation and necropsy. Both the subjectand predicate devices met the requirementsof the tests and performed identically. |
| ISO 10993-1 (2018) | Biological Evaluation of MedicalDevices - Part 1: Evaluation andTesting within a Risk ManagementProcess | The remaining biological endpoints ofAcute, Subacute / Subchronic, ChronicSystemic Toxicity, Genotoxicity andCarcinogenicity were evaluated anddocumented in a Toxicological RiskAssessment report. The evaluationconcluded that information gathered inpublished literature on the chemicalingredients, intended use, predicate deviceinformation that the risk of adverse effectsare low with respect to biological endpointsof Acute, Subacute / Subchronic, ChronicSystemic Toxicity, Genotoxicity andCarcinogenicity. |
| N/A | SEM Analysis of Subject andPredicate Devices | The SEM report summarizes comparisonbetween subject device (Centrix SDF) andpredicate device (Elevate SDF) on humantooth samples. Both the subject andpredicate devices treated teeth samples havesignificant deposits of silver on the cut |
| surface of the tooth and within the dentinaltubules. There is no discernable differencein the silver deposited on the tooth surfaceand within the dentinal tubules as a result ofexposure to subject and predicate devices. | ||
| N/A | Fluoride Release Testing. Evaluationof fluoride release in SDF treatedtooth cross sections comparingCentrix FluoroSilver Silver DiamineFluoride 38% and Predicate Device(Elevate Advantage Arrest SDF) | The study confirmed the release of fluorideat the same rate with no statisticaldifference between the groups. Themaximum fluoride concentrations wereequivalent.Subject 0.023 +/- 0.003 ppmF/mm²Predicate 0.024 +/- 0.006 ppmF/mm² |
| N/A | Dentin Permeability. Human molarteeth samples were evaluated tocalculate the % reduction of dentinpermeability using the ratio ofaverage treated volume of waterpassing through the dentin divided bythe average baseline rate of flow. | The results found that tooth samples treatedwith SDF reduced the dentin permeabilityby 97.5%. Dentin permeability is thought tobe related to dentin sensitivity. Treatmentsthat reduce dentin permeability have beenfound to stop pain due to dentin sensitivity |
| N/A | Chemical Identity Testing: MassSpectrometry (MS) performed onsubject and predicate device solutions | MS analysis found a strong match forchemical composition between the subjectand predicate device to demonstratecompositional equivalency. |
Summary of Testing
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8. SAFETY AND EFFICACY
The subject device is found to be equivalent to the predicate device based on comparative evaluation and testing. The overall safety and efficacy of FluoroSilver Silver Diamine Fluoride 38% usage for treating dentinal sensitivity has been demonstrated through testing conducted on the subject device, comparative testing between subject and predicate device and published literature.
9. CONCLUSION
Information presented supports substantial equivalence of the Centrix FluoroSilver Silver Diamine Fluoride 38% the predicate device based on similarities in intended use, design, principles of operation, performance specifications, and testing.
Centrix Inc believes that based on the indications for use, technological characteristics, and comparison to predicate devices the Centrix FluoroSilver Silver Diamine Fluoride 38% has been shown to be substantially equivalent to the predicate and have demonstrated that the device is as safe and as effective as the predicate.
§ 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.