(87 days)
K 014188
Not Found
No
The summary describes a dental polishing powder and its intended use with a dental polishing unit. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the physical properties and application of the powder.
No
The device is described as "cleaning, polishing and restoring the natural esthetics of tooth enamel," which are cosmetic or maintenance functions, not the treatment or prevention of disease typically associated with therapeutic devices. While it is classified as a Class II medical device, its intended use falls under general dental maintenance rather than therapy.
No
The device is described as cleaning, polishing, and restoring tooth enamel, which are treatment or aesthetic functions, not diagnostic ones. It is used to remove deposits and stains, not to identify medical conditions or diseases.
No
The device description clearly states it is a powder intended for use in dental polishing units, which are hardware devices. It is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Cleaning, polishing and restoring the natural esthetics of tooth enamel." This describes a procedure performed directly on the patient's teeth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description clearly states it's a "device intended for use during dental cleaning and periodontal therapy to remove deposits and stains from teeth." This further reinforces its use in a dental procedure on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnosing diseases, or providing information about a patient's health status based on in vitro testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Clinpro™ Prophy Powder is intended for use in dental polishing units. The air polishing unit produces a stream of water, air and Clinpro Prophy Powder to clean and polish tooth surfaces.
Cleaning, polishing and restoring the natural esthetics of tooth enamel
Product codes
KOJ
Device Description
Clinpro Prophy Powder is classified as a class II medical device because it is a device intended for use during dental cleaning and periodontal therapy to remove deposits and stains from teeth (Ultrasonic Scaler, 21 C.F.R. § 872.4850).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth enamel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental polishing units
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)
The substantial equivalence to the predicate device and the performance and blocompatibility data provide evidence that safety and effectiveness requirements of Clinpro Prophy Powder are completely met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 014188
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.”
0
AUG 0 1 2002
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
| Company: | 3M ESPE AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Official Correspondent: | Dr. Andreas Petermann, |
| Manager U.S. Regulatory Affairs | |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | Andreas.Petermann@mmm.com |
| US Agent: | Don H. McKenzie |
| Regulatory Manager | |
| Phone: | 651-736-9286 |
| Fax: | 651-736-0990 |
| E-mail: | dhmckenzie@mmm.com |
| Date: | May 3, 2002 |
Name of Device
| Proprietary Name: | Clinpro™ Prophy Powder |
|---|---|
| Classification Name: | Ultrasonic Scaler |
| Common Name: | Cleaning Powder |
Predicate Device
New Prophy Powder by Dentsply .........K 014188
Description for the Premarket Notification
Clinpro Prophy Powder is classified as a class II medical device because it is a device intended for use during dental cleaning and periodontal therapy to remove deposits and stains from teeth (Ultrasonic Scaler, 21 C.F.R. § 872.4850).
1
Clinpro Prophy Powder is intended for use in dental polishing units. The air polishing unit produces a stream of water, air and Clinpro Prophy Powder to clean and polish tooth surfaces.
3M ESPE's new cleaning powder Clinpro Prophy Powder described in this premarket notification submission is, in our opinion, substantially equivalent to the predicate device New Prophy Powder by Dentsply
In our opinion, the substantial equivalence to the predicate device and the performance and blocompatibility data provide evidence that safety and effectiveness requirements of Clinpro Prophy Powder are completely met.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three birds in flight, arranged in a row. The birds are depicted with curved lines, giving them a sense of movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the birds.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 1 2002
Mr. Andreas Petermann Manager U.S. Regulatory Affairs 3M ESPE AG Dental Products ESPE Platz Seefeld.Bavaria GERMANY D-82229
Re: K021450
Trade/Device Name: Clinpro Prophy Powder Regulation Number: 872.6080 Regulation Name: Airbrush Regulatory Class: II Product Code: KOJ Dated: May 3, 2002 Received: May 6, 2002
Dear Mr. Petermann:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Petermann
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Jlatowski Directol Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Statement of Indications for Use
(As Required by 21 C.F.R. § 801.109)
510(k) Number:
Device Name:
Clinpro Prophy Powder
Indications for use:
Cleaning, polishing and restoring the natural esthetics of tooth enamel
Prescription use: প্র
Over-the counter use □
Susan Ranre
(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devices, KOS 1450 ---510(k) Number ________________________________________________________________________________________________________________________________________________________________