(256 days)
· Professional cleaning of teeth: Removal of subgingival and supragingival plaque-biofilm and stains
· Professional cleaning of teeth including patients with dentin hypersensitivity
· Treatment of dentin hypersensitivity by blockage of the dentin tubules
· Can also be used in the presence of fixed orthodontic devices (brackets), restorative and prosthetic materials, and implants
· For maintenance in periodontitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth
· For maintenance in perimplantitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth
Clean & More is classified as airbrush (21 C.F.R. § 872.6080) because it is a powder to be used with air polishing devices in the professional tooth cleaning.
Clean & More is a prophylactic powder for gentle and professional sub- and supragingival cleaning of teeth, including the removal of plaque-biofilm and stains, using commercially available air polishing devices.
Clean & More is a glycine based air polishing powder containing functionalized tri-calcium phosphate, a substance which blocks open dentin tubules on the tooth surface, thereby contributing to a reduction in dentin hypersensitivity.
Here's an analysis of the acceptance criteria and study information for the "Clean & More" device, based on the provided document:
The document (K151748) describes a 510(k) premarket notification for "Clean & More," a prophylactic powder for professional tooth cleaning. The primary purpose of the submission is to demonstrate substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria. Therefore, the "acceptance criteria" for the device are largely implied by its performance being equivalent to the predicate devices and demonstrating safety and efficacy for its stated Indications for Use.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) summary demonstrating substantial equivalence, formal, quantitative acceptance criteria are not explicitly stated in the same way they would be for a direct performance claim against a specific standard. Instead, the "acceptance criteria" are implied by the requirement for the new device to perform equivalently to its predicate devices in various aspects.
| Acceptance Criterion (Implied) | Reported Device Performance (Clean & More) |
|---|---|
| Cleaning Effect (compared to predicate) | Equal cleaning effect compared to Clinpro Prophy Powder. |
| Plaque Removal Efficiency (compared to predicate) | Very efficient plaque removal from bovine enamel, comparable to Clinpro Prophy Powder. |
| Surface Roughness (bovine enamel) (compared to predicate) | No statistically significant difference in surface roughness of bovine enamel after cleaning with Clean & More vs. Clinpro Prophy Powder. Gentle cleaning effect. |
| Surface Roughness (composite materials) (compared to predicate) | No statistically significant difference in surface roughness of composite materials after cleaning with Clean & More vs. Clinpro Prophy Powder. |
| Abrasion (bovine enamel) (compared to predicate) | Minimally detectable abrasion, similar to Clinpro Prophy Powder. |
| Abrasion (bovine dentin) (compared to predicate) | Nearly as low as abrasion on bovine enamel, similar to Clinpro Prophy Powder. No differences to enamel when using glycine-based air polishing powders. |
| Plaque-Biofilm Removal (zirconia & titanium) (compared to predicate) | Equivalent to treatment with Clinpro Prophy Powder. |
| Reduction of Dentin Hypersensitivity | Statistically significant hypersensitivity relief based on tactile stimuli at 10 days and up to 4 weeks. (This directly supports its extended indication for hypersensitivity treatment, where the predicate did not explicitly cover it in the same way, but reference devices did). The study aimed to determine pain level during treatment with subsequent reduction of hypersensitivity, and the sustainability of the effect. |
| Biocompatibility | Assessed by a board-certified toxicologist according to FDA guidance and international standards (ISO 10993 series and ISO 7405). The conclusion is that Clean & More is safe for its intended use. This is a pass/fail criterion based on compliance with established biological safety standards. |
| Chemical Composition, Performance, Fundamental Technology, and Intended Use (Overall Substantial Equivalence) | Chemical composition includes glycine based prophy powder containing functionalized tricalcium phosphate. Performance described above. Fundamental technology is dental prophylaxis powder and dentin tubule occlusion. Intended uses align with predicate for cleaning but extend to explicit dentin hypersensitivity treatment, shown to be addressed by reference devices. Overall: Demonstrates substantial equivalence by incorporating elements of primary and reference predicates, and data supports all indications. |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Study Test Set:
- Sample Size: A total of 40 subjects were enrolled.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study. It was conducted "according to ISO 14155:2011 - Good Clinical Practice (GCP)," which suggests international standards were followed. It is a prospective study, as subjects were enrolled, treated, and followed up at specific intervals (10 days, 4 weeks, 3 and 6 months).
- Non-Clinical (In vitro) Test Set:
- Sample Materials: Bovine enamel, composite materials, bovine dentin, zirconia surfaces, and titanium surfaces.
- Data Provenance: Not specified, but generally in vitro studies are conducted in a controlled lab environment. This data is prospective in the sense that the experiments were designed and executed to test the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Clinical Study:
- Dentin Hypersensitivity: Ground truth for hypersensitivity was "predetermined hypersensitivity on at least two teeth determined by air blast and tactile scoring." The document does not specify the number or qualifications of the experts (e.g., dentists, hygienists) who performed these initial assessments or subsequent evaluations.
- Non-Clinical (In vitro) Studies:
- The "ground truth" for these studies is the experimental measurement and comparison to the predicate device's performance. Experts would include the researchers conducting the tests and analyzing the data, but no specific number or qualifications are provided.
4. Adjudication Method for the Test Set
- Clinical Study: Not explicitly stated. The determination of "predetermined hypersensitivity" and subsequent assessment of "incidence and degree of dentinal hypersensitivity" would imply a clinical evaluation, but no multi-reader adjudication method (like 2+1 or 3+1) is mentioned. "Air blast and tactile scoring" are common methods, and typically, the assessing clinician's findings serve as the "ground truth" for that individual.
- Non-Clinical (In vitro) Studies: Not applicable in the same way as clinical adjudication. Data analysis of measurements and observations (e.g., Keyence microscope observation, statistical evaluation) would be the method to determine "truth."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not explicitly done or mentioned.
- The clinical study focused on the effectiveness of Clean & More in reducing dentin hypersensitivity in a cohort of patients. It describes the device's performance, not a comparison of human readers with and without AI assistance.
- The non-clinical studies were direct comparisons of material properties and performance between the new device and its predicate, not involving human readers' diagnostic accuracy.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in spirit, the clinical and non-clinical studies can be considered standalone performance for the device itself.
- The in vitro tests directly assessed the physical and chemical performance of the Clean & More powder. This is an "algorithm only" type of test in the sense that it's the device's inherent performance being measured.
- The clinical study evaluated the direct effect of the Clean & More treatment on patients' dentin hypersensitivity relief. This is the "standalone" performance of the therapeutic intervention itself; it's not assessing a diagnostic algorithm or a human reader's interpretation.
7. The Type of Ground Truth Used
- Clinical Study: The ground truth for dentin hypersensitivity was established by expert clinical assessment (air blast and tactile scoring) of pre-existing hypersensitivity and subsequent changes after treatment. This effectively represents a clinical outcome and patient-reported state (pain level).
- Non-Clinical (In vitro) Studies: The ground truth was based on objective laboratory measurements of physical properties (e.g., surface roughness, abrasion levels, plaque removal efficiency) using scientifically accepted methods and instrumentation.
8. The Sample Size for the Training Set
- The document does not explicitly mention a "training set" because this product is a physical dental device (prophylactic powder), not a software algorithm that requires machine learning training data. The studies conducted are for performance validation, not for training an AI model.
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of a "training set" in the context of an AI/ML algorithm for this device, this question is not applicable. The device's formulation and design would be based on prior scientific research and development, not on a machine learning training process.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three profiles of human faces incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2016
3M Deutschland GmbH Dr. Desi W. Soegiarto Group Leader Regulatory Affairs Medical Devices ESPE Platz Seefeld, Bavaria 82234 GERMANY
Re: K151748
Trade/Device Name: Clean & More Regulation Number: 21 CFR 872.6080 Regulation Name: Airbrush Regulatory Class: II Product Code: PIP Dated: January 15, 2016 Received: January 19, 2016
Dear Dr. Soegiarto:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang -
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151748
Device Name Clean & More
Indications for Use (Describe)
· Professional cleaning of teeth: Removal of subgingival and supragingival plaque-biofilm and stains
· Professional cleaning of teeth including patients with dentin hypersensitivity
· Treatment of dentin hypersensitivity by blockage of the dentin tubules
· Can also be used in the presence of fixed orthodontic devices (brackets), restorative and prosthetic materials, and implants
· For maintenance in periodontitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth
· For maintenance in perimplantitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Carl-Schurz-Straße 1 41453 Neuss Germany
Postal Address: ESPE Platz 82229 Seefeld Germany
☎+49 (0)8152 700-0 鳥+49 (0)8152 700-1366 Internet: www.3MESPE.com E-Mail: info3MESPE@3M.com WEEE-Reg.-Nr. DE 36963167 VAT-ID: DE 120679179
510(k) SUMMARY: K151748
Submitter
Com
| Company: | 3M Deutschland GmbH |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number | 9611385 |
| Official Correspondent & Contact: | Dr. Desi W. Soegiarto,Regulatory Affairs |
| Phone: | +49-8152-700 1169 |
| Fax: | +49-8152-700 1869 |
| E-mail: | desi.soegiarto@mmm.com |
| Date: | March 5, 2016 |
Name of Device
| Proprietary Name: | Clean & More |
|---|---|
| Product Code: | PIP |
| Common Name: | Prophy Powder, Airbrush Accessory |
| Regulation Number: | 21 CFR 872.6080 |
Predicate Devices
| Primary Predicate Device | |
|---|---|
| Clinpro Prophy Powder | K140684by 3M Deutschland GmbH, Germany |
| Product Code: | PIP |
| Common Name: | Prophy Powder, Airbrush Accessory |
| Regulation Number: | 21 CFR 872.6080 |
Image /page/4/Picture/12 description: The image shows a logo for "Deutsche Dental Industrie". The logo consists of a circular design with three concentric arcs and a triangular shape at the bottom, resembling a stylized tooth. To the right of the circular design, the text "Deutsche Dental Industrie" is arranged vertically, indicating the organization or industry it represents.
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Reference Device 1
| OSspray Cleaning Compound | K062502by OSspray Ltd. – London, U.K. |
|---|---|
| Product Code: | EJR |
| Common Name: | Prophy Powder, Airbrush Accessory |
| Regulation Number: | 21 CFR 872.6030 |
Reference Device 2
| Vanish Varnish, 5% Sodium Fluoride White Varnish | K092141 |
|---|---|
| Product Code: LBH | |
| Common Name: | |
| Regulation Number: |
Device Description
Clean & More is classified as airbrush (21 C.F.R. § 872.6080) because it is a powder to be used with air polishing devices in the professional tooth cleaning.
Clean & More is a prophylactic powder for gentle and professional sub- and supragingival cleaning of teeth, including the removal of plaque-biofilm and stains, using commercially available air polishing devices.
Clean & More is a glycine based air polishing powder containing functionalized tri-calcium phosphate, a substance which blocks open dentin tubules on the tooth surface, thereby contributing to a reduction in dentin hypersensitivity.
Indications for Use
- · Professional cleaning of teeth: Removal of subgingival plaque-biofilm and stains
- · Professional cleaning of teeth including patients with dentin hypersensitivity
- · Treatment of dentin hypersensitivity by blockage of the dentin tubules
· Can also be used in the presence of fixed orthodontic devices (brackets), restorative and prosthetic materials, and implants
• For maintenance in periodontitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth
· For maintenance in periimplantitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth
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Comparison
Chemical composition, performance, fundamental technology, and intended use of Clean & More have been compared to the predicate devices.
As Clinpro Prophy Powder (K140684, 3M Deutschland GmbH, Germany) and OSspray Cleaning Compound (K062502, OSspray Ltd, London, U.K.), Clean & More is an air polishing powder to be used with air polishing devices in the professional tooth cleaning. Whereas OSspray Cleaning Compound is composed of calcium phosphosilicate compound in powder form, Clean & More and Clinpro Prophy Powder consist of water-soluble amino acid glycine. Like OSspray Cleaning Compound and Vanish Varnish (K092141, by 3M ESPE Dental, USA), Clean & More contains chemical component to block dentin tubules in order to reduce dentinal hypersensitivity.
Comparative testing, both in vitro and in vivo, revealed equivalent results in performance of Clean & More and the predicate device.
The tables below summarize the basic composition, fundamental technology, and intended use of Clean & More and predicate devices:
| Clean & More | Clinpro ProphyPowder | OSspray CleaningCompound | Vanish Varnish, 5%Sodium FluorideWhite Varnish |
|---|---|---|---|
| Subject Device | Primary PredicateDevice | Reference PredicateDevice 1 | Reference PredicateDevice 2 |
| K151748 | K140684 | K062502 | K092141 |
| Basic Composition | |||
| Glycine based prophypowder containingfunctionalizedtricalcium phosphate | Glycine based prophypowder | Calciumphosphosilicatecompound in powderform | Varnish containingsodium fluoride andfunctionalizedtricalcium phosphate |
| Fundamental Technology | |||
| Dental prophypalxispowder, dentin tubuleocclusion | Dental prophypalxispowder | Dental prophypalxispowder, dentin tubuleocclusion | Cavity varnish, dentintubule occlusion |
| Clean & More | Clinpro ProphyPowder | OSspray CleaningCompound | Vanish Varnish, 5%Sodium FluorideWhite Varnish |
| Subject Device | Primary PredicateDevice | Reference PredicateDevice 1 | Reference PredicateDevice 2 |
| K151748 | K140684 | K062502 | K092141 |
| Indications for Use (1) / Principle of operation: Cleaning | |||
| • Professionalcleaning of teeth:Removal ofsubgingival andsupragingival plaque-biofilm and stains• Professionalcleaning of teethincluding patientswith dentinhypersensitivity• Can also be used inthe presence of fixedorthodontic devices(brackets), restorativeand prostheticmaterials, andimplants• For maintenance inperiodontitis therapyafter completion ofinitial treatment -when using standarddevices - for gingivalpockets up to 5 mm indepth• For maintenance inperiimplantitistherapy aftercompletion of initialtreatment - whenusing standarddevices - for gingivalpockets up to 5 mm indepth | • Professionalcleaning of teeth:Removal ofsubgingival andsupragingival plaque-biofilm and stains• Can also be used inthe presence of fixedorthodontic devices(brackets), restorativeand prostheticmaterials, andimplants• For maintenance inperiodontitis therapyafter completion ofinitial treatment -when using standarddevices - for gingivalpockets up to 5 mm indepth• For maintenance inperiimplantitistherapy aftercompletion of initialtreatment - whenusing standarddevices - for gingivalpockets up to 5 mm indepth | The OSsprayCleaning Compoundis intended forcleaning andpolishing proceduresas part of aprofessionallyadministered dentalprophylaxis treatment. | --- |
Tab. Substantial equivalence: Comparison of basic composition and fundamental technology
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Tab. Substantial equivalence: Comparison of Indications for Use (1
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| Tab. Substantial equivalence: Comparison of Indications for Use (2 |
|---|
| -------------------------------------------------------------------- |
| Clean & More | Clinpro ProphyPowder | OSspray CleaningCompound | Vanish Varnish, 5%Sodium FluorideWhite Varnish |
|---|---|---|---|
| Subject Device | Primary PredicateDevice | Reference PredicateDevice 1 | Reference PredicateDevice 2 |
| K151748 | K140684 | K062502 | K092141 |
| Indications for Use (2) / Principle of operation: Mechanical occlusion of dentin tubuli | |||
| • Treatment of dentinhypersensitivity byblockage of the dentintubules | --- | The OSsprayCleaning Compoundis also intended toprovide relief fromtooth sensitivityduring theprophylaxis treatment. | Treatment ofhypersensitive teethUse on exposeddentin and rootsensitivity |
Performance Data: Non-clinical Performance Testing
In vitro testing was conducted to examine cleaning effect, plaque removal from bovine enamel, surface roughness of bovine enamel and composite materials, abrasion of bovine enamel and dentin, and removal of plaque-biofilm on zirconia and titanium surfaces comparing the performance of Clean & More to Clinpro Prophy Powder (K140684).
Standards: Not applicable. There are no standards specifically for prophy powders.
The cleaning effect of Clean & More is equal compared to Clinpro Prophy Powder air polishing powder.
Plaque removal from bovine enamel was very efficient with Clinpro Prophy Powder as well as Clean & More. Plaque removal efficiency of Clean & More is comparable to Clinpro Prophy Powder.
Statistical evaluation of the surface roughness data showed no difference in surface roughness of bovine enamel surface after cleaning with Clean & More and Clinpro Prophy Powder.
ANOVA evaluation of observations of composition materials after cleaning with Clean & More and after cleaning with Clinpro Prophy Powder revealed no statistically significant difference in surface roughness.
The abrasion of bovine enamel was minimally detectable for Clean & More and Clinpro Prophy Powder.
The abrasions of bovine dentin caused by Clean & More and Clinpro Prophy Powder were nearly as low as the abrasion on bovine enamel.
Keyence microscope observation revealed a gentle cleaning effect on enamel surface with Clean & More and Clinpro Prophy Powder.
Surface analysis of dentine showed no differences to enamel when using the glycine based air polishing powders: Clean & More and Clinpro Prophy Powder.
Tests have shown that plaque-biofilm removal on zircon and titanium surfaces with Clean & More was equivalent to treatment with Clinpro Prophy Powder.
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Performance Data: Clinical Study
Effect of Clean & More for professional cleaning of teeth including patients with dentin hypersensitivity and treatment of dentin hypersensitivity has been shown in a Clinical study conducted according to ISO 14155:2011 - Good Clinical Practice (GCP). The objective of the study was to determine pain level during treatment with subsequent reduction of hypersensitivity, and the sustainability of the effect. A total of 40 subjects were enrolled with predetermined hypersensitivity on at least two teeth determined by air blast and tactile scoring. After providing the Clean & More treatment the incidence and degree of dentinal hypersensitivity was again determined after treatment, at 10 days, 4 weeks and 3 and 6 months. Treatment with Clean & More resulted in statistically significant hypersensitivity relief based on tactile stimuli at 10 days and up to 4 weeks.
Performance Data: Biocompatibility Testing
The biocompatibility of Clean & More has been assessed by a board-certified toxicologist according to recommendations in FDA guidance and internationally recognized standards for medical and dental devices.
The biocompatibility assessment for this product was conducted in accordance with the following Guidance:
l) Testing guidelines outlined in the FDA General Program Memorandum G95. 2) ISO 10993-1:2009(E) Biological evaluation of medical devices - Part I: Evaluation and testing within a risk management process; in addition, relevant detailed guidance in ISO Standards I 0993-3:2003 (Tests for genotoxicity, carcinogenicity and reproductive toxicity), 10993-5:2009 (Tests for in vitro cytotoxicity), 10993-10:2010 (Tests for irritation and skin sensitization); and 1 0993-11:2006 (Tests for systemic toxicity) was considered; 3) ISO 7405:2008 Dentistry -- Evaluation of Biocompatibility of Medical Devices in Dentistry;
Conclusions
Performance test results from comparative in vitro testing together with results from comparative clinical testing to evaluate reduction in dental hypersensitivity after cleaning using Clean and More and Clinpro Prophy Powder, demonstrate that Clean and More blocks dentin tubules, cleans tooth surfaces and provides relief for patients suffering from dentinal hypersensitivity. The conclusion of the biocompatibility assessments is that Clean & More is safe for its intended use.
Substantial Equivalence Statement
The contents of this 510(k) premarket notification for Clean & More demonstrate substantial equivalence to the predicate devices for basic composition, fundamental technology, performance, and indications for use. Although the indications are not exactly identical to the predicates this new device incorporates the elements of the primary and reference predicates. Data has been presented for each of these indications. The data and clinical use supports that the inclusion of treatment of hypersensitivity during dental prophylaxis.
§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”