(87 days)
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
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). 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.
The provided text describes a 510(k) summary for a dental cleaning powder, Clinpro™ Prophy Powder, and its substantial equivalence determination by the FDA. However, it does not contain the information required to populate the requested table and answer the questions related to acceptance criteria, device performance, and study details for an AI/software device.
The document discusses:
- Device Name: Clinpro™ Prophy Powder
- Classification: Class II medical device, Ultrasonic Scaler (21 C.F.R. § 872.4850), later identified as Airbrush (21 CFR 872.6080)
- Intended Use: Cleaning, polishing, and restoring the natural aesthetics of tooth enamel; specifically for use in dental polishing units to produce a stream of water, air, and powder to clean and polish tooth surfaces.
- Predicate Device: New Prophy Powder by Dentsply (K014188)
- Conclusion: The submitter believes the device is substantially equivalent to the predicate device and that performance and biocompatibility data provide evidence that safety and effectiveness requirements are met.
There is no mention of:
- Acceptance criteria in terms of metrics (e.g., sensitivity, specificity, accuracy).
- Reported device performance values for such metrics.
- Any clinical study, test set, training set, or ground truth details.
- AI/software components, human readers, or comparative effectiveness studies.
Therefore, I cannot fulfill the request as the provided text is for a physical dental cleaning powder undergoing a 510(k) submission, not an AI/software device evaluation.
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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. McKenzieRegulatory 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).
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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.
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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.
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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
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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 ________________________________________________________________________________________________________________________________________________________________
§ 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.”