(220 days)
Not Found
No
The summary describes a glycine-based powder for air polishing devices and does not mention any AI or ML components.
Yes
The device is used for maintenance in periodontitis and periimplantitis therapy after completion of initial treatment, which are conditions that require therapeutic intervention for healing or management.
No
The device, Clinpro TM Prophy Powder, is described as an airbrush powder used for professional tooth cleaning, specifically for the removal of plaque and for maintenance therapies. Its intended use focuses on treatment and cleaning, not on diagnosing medical conditions.
No
The device is described as a powder (Clinpro TM Prophy Powder) used with air polishing devices, which are hardware components. The description explicitly states it is a powder and compares it to other powders used in professional tooth cleaning.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the physical removal of plaque and for maintenance in periodontal and peri-implantitis therapy. This is a therapeutic and cleaning function performed directly on the patient's teeth and gums.
- Device Description: The device is described as a powder used with air polishing devices for professional tooth cleaning. This aligns with a physical cleaning process.
- Lack of Diagnostic Function: 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 testing.
- Anatomical Site: The anatomical sites mentioned (subgingival, supragingival, gingival pockets, peri-implantitis) are where the cleaning action is performed, not where a sample is collected for in vitro analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical cleaning and maintenance.
N/A
Intended Use / Indications for Use
· Removal of subgingival and supragingival plaque; can also be used in the presence of permanent orthodontic apparatus (brackets) and implants
· For maintenance in periodontitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only
· For maintenance in periimplantitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only Calculi and tartar cannot be removed with Clinpro Prophy Powder.
Product codes
PIP
Device Description
Clinpro TM Prophy Powder 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.
As the predicate devices Air-N-Go® Perio Powder (K110379) and Air-Flow® Perio Powder (K092289), Clinpro Prophy Powder is a glycine based air polishing powder to be used with air polishing devices in the professional tooth cleaning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Several investigations have been carried out to characterize the performance and safety of Clinpro Prophy Powder and glycine-based powder to be used in professional tooth cleaning. Published in vitro and in vivo studies support this characterization.
The major focus of the studies evaluated to substantiate performance and safety of Clinpro Prophy Powder was on the following procedures/effects:
-Removal of subgingival bacterial load in supportive periodontal therapy;
-Root debridement;
- Use on contaminated implant material; -
-Professional oral hygiene treatment of patients with orthodontic appliances -(effects on plaque index (PI) and gingival bleeding);
-Gingival tissue effects; - - -Abrasiveness of air-polishing.
The overall conclusion, based also on the clinical literature review, is that Clinpro Prophy Powder is suitable and safe for its intended use.
Biocompatibility testing was carried out. Biocompatibility evaluations have been performed for Clinpro Prophy Powder in consideration of FDA & internationally recognized guidelines. The conclusion of the assessments is that Clinpro Prophy Powder is biocompatible for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.”
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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2014
3M Deutschland Gmbh Dr. Desi Soegiarto Regulatory Affairs Specialist ESPE Platz Seefeld, D-D82229 GERMANY
Re: K140684
Trade/Device Name: Clinpro Prophy Powder Regulation Number: 21 CFR 872.6080 Regulation Name: Airbrush Regulatory Class: II Product Code: PIP Dated: September 23, 2014 Received: September 25, 2014
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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education 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 vours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH 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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K140684
Device Name Clinpro™ Prophy Powder
Indications for Use (Describe)
· Removal of subgingival and supragingival plaque; can also be used in the presence of permanent orthodontic apparatus (brackets) and implants
- · For maintenance in periodontitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only
· For maintenance in periimplantitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only Calculi and tartar cannot be removed with Clinpro Prophy Powder.
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)
FORM FDA 3881 (1/14)
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K140684: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
| 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 Specialist | |
| Phone: | +49-8152-700 1169 |
| Fax: | +49-8152-700 1869 |
| E-mail: | desi.soegiarto@mmm.com |
| Date: | March 13, 2014 |
| (revised on October 24, 2014 |
Name of Device
| Proprietary Name: | ClinproTM Prophy Powder |
|---|---|
| Product Code: | PIP |
| Common Name: | Prophy Powder, Airbrush Accessor |
| Regulation Number: | 21 CFR 872.6080 |
Predicate Devices
Air-N-Go® Perio Powder: K110379 by Satelec – Acteon Group, France Air-Flow® Perio Powder: K092289 by EMS Electro Medical Systems SA, Switzerland
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Description for the Premarket Notification
| | Clinpro™
Prophy Powder
(K021450) | Air-N-Go®
Perio Powder
(K110379) | Air-Flow® Perio
Powder
(K092289) | Results of
comparison |
|---------------------------------------------------|----------------------------------------|----------------------------------------|----------------------------------------|-----------------------------|
| Powder to be
used with air
polishing device | Yes | Yes | Yes | Substantially
equivalent |
| Glycine based | Yes | Yes | Yes | Substantially
equivalent |
| Subgingival use | Yes | Yes | Yes | Substantially
equivalent |
| Supragingival use | Yes | Yes | No | Substantially
equivalent |
Clinpro TM Prophy Powder 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.
As the predicate devices Air-N-Go® Perio Powder (K110379) and Air-Flow® Perio Powder (K092289), Clinpro Prophy Powder is a glycine based air polishing powder to be used with air polishing devices in the professional tooth cleaning.
Comparison of Clinpro Prophy Powder and the predicate devices Air-N-Go® Perio Powder (K110379) and Air-Flow® Perio Powder (K092289) with regard to its indications for use shows that Clinpro Prophy Powder is substantially equivalent to the predicate devices. As the predicate devices, Clinpro Prophy Powder is a powder for suband supragingival plaque removal. When applied subgingivally, it may be used as an adjunct to support periodontitis and periimplantitis therapy.
Results of in vitro and in vivo investigations using Clinpro Prophy Powder and glycine based air-polishing powder (i.a.) published in numerous literature show that Clinpro Prophy Powder is substantially equivalent to the predicate device with regard to the performance of the product.
The particle size of Clinpro Prophy Powder has been determined by laser light diffraction measurement on the particles suspended in isopropanol.
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Comparison for indications for use, performance, and chemistry shows that Clinpro Prophy Powder is substantially equivalent to the predicate devices.
Several investigations have been carried out to characterize the performance and safety of Clinpro Prophy Powder and glycine-based powder to be used in professional tooth cleaning. Published in vitro and in vivo studies support this characterization.
The major focus of the studies evaluated to substantiate performance and safety of Clinpro Prophy Powder was on the following procedures/effects:
- -Removal of subgingival bacterial load in supportive periodontal therapy;
- -Root debridement;
- Use on contaminated implant material; -
- Professional oral hygiene treatment of patients with orthodontic appliances -(effects on plaque index (PI) and gingival bleeding);
- Gingival tissue effects; -
- -Abrasiveness of air-polishing.
The overall conclusion, based also on the clinical literature review, is that Clinpro Prophy Powder is suitable and safe for its intended use.
Biocompatibility testing was carried out. Biocompatibility evaluations have been performed for Clinpro Prophy Powder in consideration of FDA & internationally recognized guidelines. The conclusion of the assessments is that Clinpro Prophy Powder is biocompatible for its intended use.
In summary, it can be concluded that Clinpro Prophy Powder is substantially equivalent in safety and effectiveness with the predicate devices Air-N-Go® Perio Powder (K110379) and Air-Flow® Perio Powder (K092289).
Indications for Use
- · Removal of subgingival and supragingival plaque; can also be used in the presence of permanent orthodontic apparatus (brackets) and implants
- · For maintenance in periodontitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only
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• For maintenance in periimplantitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only
Calculi and tartar cannot be removed with Clinpro Prophy Powder.