(68 days)
This product is to be used for cleaning and polishing as a professionally administered prophylaxis treatment. Secondarily, MI Paste can be used for the management of tooth sensitivity, postscaling, root planing and bleaching.
Not Found
I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) clearance letter for a dental product called "MI Paste," classifying it and stating its indications for use. It doesn't include details about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for a device performance study.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2004
Ms. Terry L. Joritz Director, Regulatory Affairs & Quality Control GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K042200
Trade/Device Names: MI Paste Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: August 12, 2004 Received: August 23, 2004
Dear Ms. Joritz:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have leviewed your booken of the device is substantially equivalent (for the indications for referenced and nave and have a colemally marketed predicate devices marketed in interstate commerce use stated in the eneround date of the Medical Device Amendments, or to devices that provisions in the may 20, 1970, mo encenters 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 therefore, mainer the detises, ac your wear in manual registration, listing of devices, good controls provisions or allabeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de rice is olassilled (see a controls. Existing major regulations affecting your device can be may be subject to sublications. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Ms. Terry L. Joritz
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised mat FDA s Issualice of a substition with other requirements of the Act or that FDA has made a determination that your ceval agencies. You must comply with any Federal statures and regulations administered by outdiving (21 CFR Part 807);
all the Act's requirements, including, but not limited to: registration and forth in the qua all the Act's requirements, including, but ior inniter to requirements as set forth in the quality.
Ilabeling (21 CFR Part 801); good manufacturer in the coloration product r labeling (21 CFR Part 801), good manufacturing provinsble, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic produ systems (QS) regulation (21 C2 -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) I his letter will allow you to obgin manxeting your antial equivalence of your device to a legally premarket notification. The FDA Inding of substantal vour 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), please If you desire specific advice for your device on our and in one questions on the promotion contact the Office of Compliance at (501) 591-1010 - 1010-1941 (101) 594-4639. Also,
and advertising of your device, please contact the Office of Compliance at (2017EP and advertising of your device, prease corract in "Creference to premarket notification" (21CFR).
please note the regulation entitled, "Misbranding by reference to premailiti please note the regulation entrucca, "Misolalians on your responsibilities under the Act may Part 807.97) you may obtain. Other general 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,
Clive
Chiu S. Lin, PhD 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): _ K042200
MI PASTE Device Name:
Indications for Use:
This product is to be used for cleaning and polishing This product is to bo a professionally administered prophylaxis treatment. Secondarily, MI Paste can be used for the management of tooth sensitivity, postscaling, root planing and bleaching.
Prescription Use (21 CFR Part 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Runne
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K042201
Page 1 of 1
§ 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.