(256 days)
No
The summary describes a prophylactic powder for professional tooth cleaning and treatment of dentin hypersensitivity. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for the treatment of dentin hypersensitivity by blockage of the dentin tubules, which is a therapeutic purpose.
No
Explanation: The device is described as a prophylactic powder for professional cleaning of teeth and treatment of dentin hypersensitivity, not for diagnosing conditions. Its intended uses involve cleaning, stain removal, and blocking dentin tubules, all of which are treatment or preventative measures, not diagnostic ones.
No
The device description clearly states it is a powder (a physical substance) used with air polishing devices, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is focused on the mechanical cleaning of teeth and the treatment of dentin hypersensitivity by physically blocking tubules. These are direct treatments and procedures performed on the patient's teeth and gums.
- Device Description: The device is described as a "prophylactic powder for gentle and professional sub- and supragingival cleaning of teeth" and is classified as an "airbrush" (a type of dental device). It's a substance applied to the teeth using an air polishing device.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely therapeutic and procedural, not diagnostic.
N/A
Intended Use / 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
Product codes
PIP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth, gingival pockets, dentin tubules
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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).
Key Results:
- 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.
Clinical Study:
Study Type: Clinical study conducted according to ISO 14155:2011 - Good Clinical Practice (GCP).
Objective: To determine pain level during treatment with subsequent reduction of hypersensitivity, and the sustainability of the effect.
Sample Size: A total of 40 subjects were enrolled with predetermined hypersensitivity on at least two teeth determined by air blast and tactile scoring.
Key Results: Treatment with Clean & More resulted in statistically significant hypersensitivity relief based on tactile stimuli at 10 days and up to 4 weeks.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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.
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 (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
2
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)
3
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4
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 | K140684 |
| 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.
5
Reference Device 1
| OSspray Cleaning Compound | K062502
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
| 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
6
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
Powder | OSspray Cleaning
Compound | Vanish Varnish, 5%
Sodium Fluoride
White Varnish |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Subject Device | Primary Predicate
Device | Reference Predicate
Device 1 | Reference Predicate
Device 2 |
| K151748 | K140684 | K062502 | K092141 |
| Basic Composition | | | |
| Glycine based prophy
powder containing
functionalized
tricalcium phosphate | Glycine based prophy
powder | Calcium
phosphosilicate
compound in powder
form | Varnish containing
sodium fluoride and
functionalized
tricalcium phosphate |
| Fundamental Technology | | | |
| Dental prophypalxis
powder, dentin tubule
occlusion | Dental prophypalxis
powder | Dental prophypalxis
powder, dentin tubule
occlusion | Cavity varnish, dentin
tubule occlusion |
| Clean & More | Clinpro Prophy
Powder | OSspray Cleaning
Compound | Vanish Varnish, 5%
Sodium Fluoride
White Varnish |
| Subject Device | Primary Predicate
Device | Reference Predicate
Device 1 | Reference Predicate
Device 2 |
| K151748 | K140684 | K062502 | K092141 |
| Indications for Use (1) / Principle of operation: Cleaning | | | |
| • Professional
cleaning of teeth:
Removal of
subgingival and
supragingival plaque-
biofilm and stains
• Professional
cleaning of teeth
including patients
with dentin
hypersensitivity
• 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 | • Professional
cleaning of teeth:
Removal of
subgingival and
supragingival plaque-
biofilm and stains
• 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 | The OSspray
Cleaning Compound
is intended for
cleaning and
polishing procedures
as part of a
professionally
administered dental
prophylaxis treatment. | --- |
Tab. Substantial equivalence: Comparison of basic composition and fundamental technology
7
Tab. Substantial equivalence: Comparison of Indications for Use (1
8
| Tab. Substantial equivalence: Comparison of Indications for Use (2 |
|---|
| -------------------------------------------------------------------- |
| Clean & More | Clinpro Prophy
Powder | OSspray Cleaning
Compound | Vanish Varnish, 5%
Sodium Fluoride
White Varnish |
|-----------------------------------------------------------------------------------------|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Subject Device | Primary Predicate
Device | Reference Predicate
Device 1 | Reference Predicate
Device 2 |
| K151748 | K140684 | K062502 | K092141 |
| Indications for Use (2) / Principle of operation: Mechanical occlusion of dentin tubuli | | | |
| • Treatment of dentin
hypersensitivity by
blockage of the dentin
tubules | --- | The OSspray
Cleaning Compound
is also intended to
provide relief from
tooth sensitivity
during the
prophylaxis treatment. | Treatment of
hypersensitive teeth
Use on exposed
dentin and root
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.
9
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.