GELATO PROPHYLAXIS PASTE

K042048 · Deepak Products, Inc. · EJR · Oct 26, 2004 · Dental

Device Facts

• Record ID: K042048
• Device Name: GELATO PROPHYLAXIS PASTE
• Applicant: Deepak Products, Inc.
• Product Code: EJR · Dental
• Decision Date: Oct 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6030
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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 with fluoride contains a unique blend of polishing and cleaning agents. 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.

Device Story

Gelato Prophylaxis Paste is a dental abrasive polishing agent used by dental professionals during routine hygiene procedures. The paste is applied to tooth surfaces to remove plaque and stains; it simultaneously delivers 1.23% fluoride ion to the enamel. The device functions as a mechanical cleaning agent; it does not replace other forms of fluoride therapy. It is intended for professional use only within a clinical dental setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Abrasive polishing agent containing 1.23% fluoride ion. Classified as an oral cavity abrasive polishing agent (21 CFR 872.6030, Product Code EJR).

Indications for Use

Indicated for professional dental cleaning and polishing procedures. Intended for use by dental professionals during standard hygiene practice. Contains 1.23% fluoride ion.

Regulatory Classification

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).

Submission Summary (Full Text)

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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 [phone] or [phone] 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

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