(89 days)
Not Found
Not Found
No
The summary provides no information suggesting the use of AI or ML. The intended use and device description (though not found) point towards a standard dental prophylaxis device.
No
The device is described for cleaning and polishing procedures, which are preventative and maintenance activities, not treatments for existing diseases or conditions.
No
Explanation: The device is intended for "cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment," which are therapeutic and maintenance activities, not diagnostic ones. It does not mention identifying, detecting, or characterizing diseases or conditions.
No
The provided text describes a device used for "cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment." This strongly suggests a physical device (like a dental handpiece or polishing tool) is involved, not just software. There is no mention of software, algorithms, or digital processing.
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 dental prophylaxis treatment." This describes a physical procedure performed directly on the patient's oral cavity.
- Lack of IVD Characteristics: IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with bodily specimens.
The device is clearly intended for a direct dental procedure, not for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
Product codes (comma separated list FDA assigned to the subject device)
EJR
Device Description
Not Found
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
Professionally administered dental prophylaxis treatment.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2004
Mr. Vincent M. Tentarelli Quality Assurance Manager Pascal Company, Incorporated 2929 NE Northup Way Bellevue, Washington 98004
Re: K040661
Trade/Device Name: Radent Prophy Paste Regulation Number: 872.6030 Regulation Name: Oral Cavity Abrasvie polishing Agent Regulatory Class: I Product Code: EJR Dated: March 11, 2004 Received: March 22, 2004
Dear Mr. Tentarelli:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed young your and have determined the device is substantially equivalent (for the relered above and have and in the enclosure) to legally marketed predicate devices marketed in murcations for ass blaving to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to are rooms Act (Act) that do not require approval of a premarket the Federal F 600; Drag, Drag, therefore, market the device, subject to the general approvin uppliedicon (1 the Act. The general controls provisions of the Act include controls provisions of an 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 (1 writ), it hay of budyer in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Tentarelli
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 incall that I DIT mas made and regulations administered by other Federal agencies. of the Act of ally I oderal backed as a requirements, including, but not limited to: registration r ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF Real 807), and 1007), regulation (21 CFR Part 820); and if requirements as set form in the quarily is nontrol 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 anon yourse bogan finding of substantial equivalence of your device to a premarket notification. - I 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), 11 you desire specific at 130 Compliance at (301) 594-4613. Also, please note the regulation 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 may oveant other gallery, International and Consumer Assistance at its toll-free Drimber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Clu
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
Enclosure
2
V. STATEMENT OF INDICATIONS FOR USE
| Labels | Values |
|---|---|
| 510 (k) NUMBER (IF KNOWN): | K040661 |
| DEVICE NAME: | RADENT PROPHY PASTE |
INDICATIONS FOR USE:
To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
Susan Russo
(Division Sign-C sion Sign-Off, Infection Control, Dental
510(k) Number:
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)