(86 days)
Hawe Cleanic® Prophylaxis Paste, Nupro® Prophylaxis Paste with Fluoride
Not Found
No
The summary describes a prophy paste, a physical substance used for cleaning and polishing teeth. There is no mention of software, algorithms, or any technology that would incorporate AI or ML. The performance studies are bench tests related to the physical properties of the paste.
No
The device is described as a prophy paste used for cleaning and polishing, which are preventative and cosmetic procedures, not inherently therapeutic for a disease or condition. While it contains fluoride, which has therapeutic benefits, its intended use is for prophylaxis, not treatment of an existing condition.
No
The device is described as a prophy paste used for cleaning and polishing procedures. It is used as part of a prophylaxis treatment, which is a preventive and maintenance procedure, not a diagnostic one.
No
The device description clearly states it is a paste composed of physical components (abrasive, flavorant, colorant, fluoride), indicating 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 for "cleaning and polishing procedures as part of a professionally administered prophylaxis treatment." This describes a physical procedure performed on a patient's teeth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description lists components like an abrasive, flavorant, colorant, and fluoride. These are typical ingredients in a dental polishing paste, not reagents or components used in an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
In summary, the device is a dental product used for a physical treatment procedure, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
Product codes
EJR
Device Description
3M™ Clinpro™ Prophy Paste is composed of an abrasive, a flavorant, a colorant, and also contains fluoride.
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
The performance of the device was validated by the comparative results of the bench tests conducted including stain removal, surface roughness, and relative dentin and enamel abrasion. Based on the conclusions drawn from the safety analysis conducted for this device and the results of the bench testing, 3M™ Clinpro™ Prophy Paste is safe and effective for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Hawe Cleanic® Prophylaxis Paste, Nupro® Prophylaxis Paste with Fluoride
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6030 Oral cavity abrasive polishing agent.
(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
MAY
K99 04852
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Name: | Rebecca L. Hannack
Advanced Regulatory Affairs Associate | |
|----------------------|---------------------------------------------------------------------------------|--|
| Address: | 3M Dental Products Division
3M Center, Bldg. 260-2B-12
St. Paul, MN 55144 | |
| Telephone: | (651)737-1105 | |
| Fax: | (651)736-0990 | |
| Trade Name: | 3M™ Clinpro™ Prophy Paste | |
| Common Name: | Prophylaxis Paste | |
| Classification Name: | Oral cavity abrasive polishing agent (21 CFR 872.6030) | |
| Predicate Devices: | Hawe Cleanic® Prophylaxis Paste
Nupro® Prophylaxis Paste with Fluoride | |
3M™ Clinpro™ Prophy Paste is to be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
3M™ Clinpro™ Prophy Paste is composed of an abrasive, a flavorant, a colorant, and also contains fluoride.
3M™ Clinpro™ Prophy Paste has similar technological characteristics as the predicate devices in that they all contain an abrasive, flavorant, colorant, and fluoride. This is further validated by the comparative results of the bench tests conducted including stain removal, surface roughness, and relative dentin and enamel abrasion.
Based on the conclusions drawn from the safety analysis conducted for this device and the results of the bench testing, 3M™ Clinpro™ Prophy Paste is safe and effective for its intended use.
1
Public Health Service
MAY 1 3 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rebecca L. Hannack Advanced Regulatory Affairs Associate Minnesota Mining and Manufacturing Company Dental Products Division 3M Center, Building 260-2B-12 St. Paul, Minnesota 55144
Re : K990482 3M™ Clinpro™ Prophy Paste, Model 12611 Trade Name: Requlatory Class: I Product Code: EJR Dated: February 10, 1999 Received: February 16, 1999
Dear Ms. Hannack:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, labelinq, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Paqe 2 - Ms. Hannack
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number:
Device Name: 3M™ Clinpro™ Prophy Paste
Indications for Use:
To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K990452 |
|---|---|
| Prescription Use | ✓ |
| OR Over-the-Counter Use ______ |