Clean & More

K151748 · 3M Deutschland GmbH · PIP · Mar 11, 2016 · Dental

Device Facts

• Record ID: K151748
• Device Name: Clean & More
• Applicant: 3M Deutschland GmbH
• Product Code: PIP · Dental
• Decision Date: Mar 11, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

Clean & More is a glycine-based prophylactic powder containing functionalized tri-calcium phosphate. It is used with commercially available air polishing devices by dental professionals in a clinical setting. The powder is delivered via air stream to the tooth surface to remove subgingival and supragingival plaque-biofilm and stains. Simultaneously, the functionalized tri-calcium phosphate particles mechanically occlude open dentin tubules, providing relief from dentin hypersensitivity. The healthcare provider uses the device during routine prophylaxis or periodontal/periimplant maintenance. The output is a cleaned tooth surface and reduced patient sensitivity, benefiting patients by providing effective cleaning while managing hypersensitivity during the procedure.

Clinical Evidence

Clinical study (n=40) conducted per ISO 14155:2011 evaluated pain levels and hypersensitivity reduction. Subjects with predetermined hypersensitivity were treated with Clean & More. Hypersensitivity was assessed via air blast and tactile scoring at baseline, post-treatment, 10 days, 4 weeks, 3 months, and 6 months. Results showed statistically significant hypersensitivity relief based on tactile stimuli at 10 days and up to 4 weeks.

Technological Characteristics

Glycine-based powder containing functionalized tri-calcium phosphate. Operates via mechanical air polishing and dentin tubule occlusion. Biocompatibility assessed per ISO 10993-1, -3, -5, -10, -11 and ISO 7405:2008. No specific standards for prophy powders exist.

Indications for Use

Indicated for professional dental cleaning, including plaque-biofilm and stain removal, in patients with or without dentin hypersensitivity. Also indicated for treatment of dentin hypersensitivity via tubule blockage. Suitable for use with fixed orthodontic devices, restorative/prosthetic materials, and implants. Indicated for maintenance therapy in periodontitis and periimplantitis for gingival pockets up to 5 mm.

Regulatory Classification

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.

Special Controls

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.”

Predicate Devices

• Clinpro Prophy Powder (K140684)

Reference Devices

• OSspray Cleaning Compound (K062502)
• Vanish Varnish, 5% Sodium Fluoride White Varnish (K092141)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.

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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

☎[phone] 鳥+49 (0)8152 700-1366 Internet: www.3MESPE.com E-Mail: [e-mail] 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,<br>Regulatory Affairs |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| 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 | K140684<br>by 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 | K062502<br>by 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<br> | 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 Prophy<br>Powder | OSspray Cleaning<br>Compound | Vanish Varnish, 5%<br>Sodium Fluoride<br>White Varnish |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Subject Device | Primary Predicate<br>Device | Reference Predicate<br>Device 1 | Reference Predicate<br>Device 2 |
| K151748 | K140684 | K062502 | K092141 |
| Basic Composition | | | |
| Glycine based prophy<br>powder containing<br>functionalized<br>tricalcium phosphate | Glycine based prophy<br>powder | Calcium<br>phosphosilicate<br>compound in powder<br>form | Varnish containing<br>sodium fluoride and<br>functionalized<br>tricalcium phosphate |
| Fundamental Technology | | | |
| Dental prophypalxis<br>powder, dentin tubule<br>occlusion | Dental prophypalxis<br>powder | Dental prophypalxis<br>powder, dentin tubule<br>occlusion | Cavity varnish, dentin<br>tubule occlusion |
| Clean & More | Clinpro Prophy<br>Powder | OSspray Cleaning<br>Compound | Vanish Varnish, 5%<br>Sodium Fluoride<br>White Varnish |
| Subject Device | Primary Predicate<br>Device | Reference Predicate<br>Device 1 | Reference Predicate<br>Device 2 |
| K151748 | K140684 | K062502 | K092141 |
| Indications for Use (1) / Principle of operation: Cleaning | | | |
| • Professional<br>cleaning of teeth:<br>Removal of<br>subgingival and<br>supragingival plaque-<br>biofilm and stains<br>• Professional<br>cleaning of teeth<br>including patients<br>with dentin<br>hypersensitivity<br>• Can also be used in<br>the presence of fixed<br>orthodontic devices<br>(brackets), restorative<br>and prosthetic<br>materials, and<br>implants<br>• For maintenance in<br>periodontitis therapy<br>after completion of<br>initial treatment -<br>when using standard<br>devices - for gingival<br>pockets up to 5 mm in<br>depth<br>• For maintenance in<br>periimplantitis<br>therapy after<br>completion of initial<br>treatment - when<br>using standard<br>devices - for gingival<br>pockets up to 5 mm in<br>depth | • Professional<br>cleaning of teeth:<br>Removal of<br>subgingival and<br>supragingival plaque-<br>biofilm and stains<br>• Can also be used in<br>the presence of fixed<br>orthodontic devices<br>(brackets), restorative<br>and prosthetic<br>materials, and<br>implants<br>• For maintenance in<br>periodontitis therapy<br>after completion of<br>initial treatment -<br>when using standard<br>devices - for gingival<br>pockets up to 5 mm in<br>depth<br>• For maintenance in<br>periimplantitis<br>therapy after<br>completion of initial<br>treatment - when<br>using standard<br>devices - for gingival<br>pockets up to 5 mm in<br>depth | The OSspray<br>Cleaning Compound<br>is intended for<br>cleaning and<br>polishing procedures<br>as part of a<br>professionally<br>administered dental<br>prophylaxis 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 Prophy<br>Powder | OSspray Cleaning<br>Compound | Vanish Varnish, 5%<br>Sodium Fluoride<br>White Varnish |
|-----------------------------------------------------------------------------------------|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Subject Device | Primary Predicate<br>Device | Reference Predicate<br>Device 1 | Reference Predicate<br>Device 2 |
| K151748 | K140684 | K062502 | K092141 |
| Indications for Use (2) / Principle of operation: Mechanical occlusion of dentin tubuli | | | |
| • Treatment of dentin<br>hypersensitivity by<br>blockage of the dentin<br>tubules | --- | The OSspray<br>Cleaning Compound<br>is also intended to<br>provide relief from<br>tooth sensitivity<br>during the<br>prophylaxis treatment. | Treatment of<br>hypersensitive teeth<br>Use on exposed<br>dentin and root<br>sensitivity |

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.