(88 days)
For cleaning and polishing procedures as part of a professionally administered prophylaxis treatment. Pastes containing fluoride are not considered a replacement for other forms of fluoride therapy. Gelato dental 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.
Gelato Prophylaxis Paste
The provided text is a 510(k) cleared device letter from the FDA for "Gelato Prophylaxis Paste". This document is a clearance letter, not a study report, and therefore does not contain information about acceptance criteria, study design, or performance metrics of a device in the way a clinical trial or validation study would.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
This means the FDA did not require new performance data or a clinical study proving the device met specific acceptance criteria. Instead, the clearance is based on its "substantial equivalence" to a predicate device already on the market.
Therefore, I cannot provide the requested information from the given text because it does not exist within these documents. There is no information on:
- A table of acceptance criteria and the reported device performance: Not applicable for a 510(k) substantial equivalence determination when new performance data isn't required.
- Sample size used for the test set and the data provenance: No test set information is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications: No ground truth establishment is described.
- Adjudication method: Not described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone performance: Not applicable in this context.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable (no algorithm training is mentioned).
- How the ground truth for the training set was established: Not applicable.
The document is a regulatory clearance based on substantial equivalence, not a report of a scientific study demonstrating specific performance metrics against pre-defined acceptance criteria.
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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.
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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
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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
Page 1 of
§ 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.