(197 days)
No
The description focuses on the physical properties and intended use of a prophylaxis paste, with no mention of AI/ML capabilities or data processing.
No
The device is a prophylaxis paste used for cleaning and polishing as part of a dental procedure, not for treating a disease or condition.
No
The device is described as a prophylaxis paste used for cleaning and polishing procedures to remove dental plaque and staining. Its intended use is purely for treatment and maintenance, not for identifying the presence, nature, or absence of disease.
No
The device description clearly states it is a "premium Prophylaxis Paste with fluoride," which 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 action performed on the teeth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description states it's a "Prophylaxis Paste with fluoride that gently removes dental plaque and staining." This further reinforces its function as a cleaning and polishing agent, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Anatomical Site: While the oral cavity is mentioned, the action is on the surface of the teeth, not an internal analysis.
- Predicate Devices: The listed predicate devices (Prophylaxis Pastes) are also not IVDs.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The ProActive Carem Prophylaxis Paste with Fluoride is to be used for cleaning and polishing procedures as part of a professionally administrated prophylaxis treatment.
To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
Product codes
EJR
Device Description
The ProActive Carem is a premium Prophylaxis Paste with fluoride that gently removes dental plaque and staining. It is a unique blend of polishing and cleaning agents designed for professional application during standard dental practice hygiene procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional application during standard dental practice hygiene procedures.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nupro® T Prophylaxis Paste with Fluoride and Triclosan ( K000169), ProClude® (K002989), 3M™ Clinpro™ Prophy Paste (K990482)
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
Ko33785
Proshulax 19
Image /page/0/Picture/1 description: The image shows the logo for Discus Dental Incorporated. The words "DISCUS DENTAL" are in large, bold, sans-serif font, with "DISCUS" in white on a black background and "DENTAL" in black on a white background. Below this, the word "INCORPORATED" is written in a smaller, sans-serif font.
JUN 1 8 2004
II. Summary of Safety and Effectiveness
ProActive Care™ Prophylaxis Paste with Fluoride
-
- Date of Summary:
- November 20, 2003 Date of Summary 2. Preparation:
- Discus Dental, Inc. 3. Applicant:
- Vivian Lai, MS Contact Person: 4. Associate, Regulatory Affairs Discus Dental, Inc. 8550 Higuera Street Culver City, CA 90232 310.845.8347 310.845.1537
5. Name of Medical Device:
| Proprietary Name: | ProActive Care™ Prophylaxis Paste with Fluoride |
|---|---|
| Common/Usual Name: | Prophylaxis Paste |
| Classification Name: | Oral cavity abrasive polishing agent |
6. Description of Medical Device
The ProActive Carem is a premium Prophylaxis Paste with fluoride that gently removes dental plaque and staining. It is a unique blend of polishing and cleaning agents designed for professional application during standard dental practice hygiene procedures.
7. Intended Use
The ProActive Carem Prophylaxis Paste with Fluoride is to be used for cleaning and polishing procedures as part of a professionally administrated prophylaxis treatment.
1
Image /page/1/Picture/0 description: The image shows the logo for Discus Dental Incorporated. The logo is split into two sections, with the left side being white and the right side being black. The words "DISCUS DENTAL" are written in bold, uppercase letters across the two sections. Below the main text, the word "INCORPORATED" is written in smaller, uppercase letters.
KC3R785
510(k) Notification November 20, 2003 310(K) Notthcation November Paste with Fluoride
Substantial Equivalence Determination 8.
The ProActive Care™ Prophylaxis Paste is substantially equivalent to the following products:
- a) Nupro® T Prophylaxis Paste with Fluoride and Triclosan ( K000169)
- b) ProClude® (K002989)
- c) 3M™ Clinpro™ Prophy Paste (K990482)
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 2004
Ms. Vivian Lai Associate, Regulatory Affairs Discus Dental, Incorporated 8550 Higuera Street Culver City, California 90232
Re: K033785
Trade/Device Name: ProActive Carem Prophylaxis Paste with Fluoride Regulation Number: 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: March 31, 2004 Received: March 5, 2004
Dear Ms. Lai:
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 nnerstate over and on 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 controls provided 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 (1 Nr.), it nay over any addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 -Ms. Lai
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 modifine Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of any I oderal classes in a suirements, including, but not limited to: registration r ou must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF re rur 007), assisted (QS) regulation (21 CFR Part 820); and if requirements as bet form nroduct 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) This letter will and not your finding of substantial equivalence of your device to a premaired 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), if you desire specific at .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj obtain 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,
Clus L
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/4/Picture/0 description: The image shows the logo for Discus Dental Incorporated. The words "DISCUS DENTAL" are in bold, uppercase letters on the top line, with "DISCUS" on a white background and "DENTAL" on a black background. Below that, the word "INCORPORATED" is spelled out in uppercase letters.
510(k) Notification November 20, 2003 310(K) Nonzivem Prophylaxis Paste with Fluoride
Indications for Use Statement V.
510 (k) Number: K033785
Device Name: ProActive Care™ Prophylaxis 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)
CONDUCTION – CONTINUE Offer of Davise Firelystion (ODE) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR Section 801.109 OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Susan Runn
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, Gental Devices Division of Anesthesions
510(k) Number: