(88 days)
Not Found
Not Found
No
The 510(k) summary describes a dental prophylaxis paste, a physical substance used for cleaning and polishing teeth. There is no mention of any software, algorithms, or data processing capabilities that would indicate the presence of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
This device is described as a polishing and cleaning paste, containing fluoride, used for prophylaxis treatment. While it contributes to oral health, its primary intended use is for cleaning and polishing, not directly treating a disease or condition as a therapeutic device. The fluoride content is for prevention rather than active therapy.
No
The intended use describes the device for cleaning and polishing procedures, which are preventative and maintenance treatments, not for diagnosing diseases or conditions.
No
The device description clearly states "Gelato Prophylaxis Paste," indicating 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 teeth as part of a prophylaxis treatment. This is a physical procedure performed directly on the patient's body (oral cavity).
- Device Description: It's a prophylaxis paste, a substance applied to the teeth.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not involve the examination of specimens outside the body.
- No Mention of Diagnostic Purpose: The intended use is purely for cleaning and polishing, not for diagnosing any condition.
Therefore, Gelato Prophylaxis Paste falls under the category of a dental device used for treatment/procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. Prophy pastes containing fluoride are not considered a replacement for other forms of fluoride therapy. Gelato dental prophylaxis paste with fluoride contains a unique blend of polishing and cleaning agents and is designed for application during standard dental practice hygiene procedures. This product contains fluoride at a concentration of 1.23% fluoride ion.
Product codes
EJR
Device Description
Not Found
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
Professionally administered dental prophylaxis treatment, professional use only, 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): 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
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three overlapping lines, which is the symbol of the Department of Health & Human Services.
OCT 2 6 2004
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ricardo A. Carles President Deepak Products, Incorporated 5220 NW 72nd Avenue, Bay #15 Miami, Florida 33166
Re: K042048
Trade/Device Name: Gelato Prophylaxis Paste Regulation Number: 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: July 12, 2004 Received: August 16, 2004
Dear Mr. Carles:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becases is see ice 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 Interstate commerce pror to that have been reclassified in accordance with the provisions of Amendinents, on to do roob and mortic Act (Act) that do not require approval of a premarket the rederal 1 000; Drag, and Cobu may, therefore, market the device, subject to the general approval uppression (1 the Act. The general controls provisions of the Act include controls providions 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 If your device is classified (500 as 10) in a controls. Existing major regulations affecting (1 Mr), it may of such to and in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be foundsh further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Carles
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualled of a basetan its with other requirements
mean that FDA has made a determination that your device Federal agencies mean that FDA nas made a decemmanding and regulations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by spical to spe of the Act of any rederal statutes and regirements, including, but not limited to: registration
You must comply with all the Act's requirements and manufacturing progrice You must comply with an the Fec s roq 2.1. CFR Part 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); CFR Part 800); and i and listing (21 CPK Part 807), labeling (21 OFF Crick recoly) (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 821, 542 requirements as set forth in the quality systems (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 5 10(k) I his letter will anow you to ocgin malicanty 762 - 10 stantial equivalence of your device to a premarket notification. The PDA miding of onsentation 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 auvice for your de recolor of the Also, please note the regulation please contact the Office or Ochiphanes an (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ola
Shixiao Xie, Ph.D.
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
Indications for Use
510(k) Number (if known): K042048
Device Name: Gelato Prophy Paste
Indications For Use:
For cleaning and polishing procedures as part of a professionally administered r of cleaning and polishing probecares as were containing fluoride are not considered a replacement for other forms of fluoride therapy.
Gelato dental prophylaxis paste with fluoride contains a unique blend of polishing and Oclain doman prophylaxis Paste is for professional use only and is designed for application during standard dental practice hygiene procedures.
This product contains fluoride at a concentration of 1.23% fluoride ion.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russr
(Division Sign-Off) (Division Sign-Only Infection Control, Dental Device
510(k) Number: K190048
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