The provided text is a 510(k) summary for a medical device called "Gridlock 195," an orthodontic adhesive. It contains administrative details, classification information, and a comparison to a predicate device ("SmartBond" bonding agent K981036). However, this document does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the request.

It merely states that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. This type of submission (510(k)) focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical efficacy or performance study data with specific acceptance criteria as might be seen in a PMA (Premarket Approval) application or a clinical trial report.

Therefore, I cannot provide the requested information based on the given text.

No information regarding acceptance criteria, device performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details is present in the provided 510(k) summary.

Summary

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MAY 0-1 2002

Kczolbus

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. Sponsor Identification

Denis Slawsby Name: Manager Title: ALLODEX Systems Company Name: Address: 10195 East Wethersfield Road Scottsdale, Arizona 85260 (888) 820-5836 Phone: Fax: (480) 451-9361

Official Contact Person:
Date of Preparation of Summary
Device Proprietary Name
Common Name
Classification Name
Class and Reference
Predicate device:
Device Description:

Denis Slawsby

Feb 27, 2002

Gridlock 195

Orthodontic adhesive

Adhesive, bracket & tooth conditioner

Class II (21 CFR 872.3750)

"SmartBond" bonding agent K981036

Cyanoacrylate adhesive

13910 North Frank Lloyd Wright Boulevard, Suite 2A/PMB 393, Scottsdale, Arizona 85260-2021 Tel: (888) 820-5836 Fax: (480) 451-9361 www.allodex.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. 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 three human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 1 2002

Dr. Melvyn A. Steinberg Director of Dental Products Allodex Systems 10195 East Weathersfield Road Scottsdale, Arizona 85260

Re: K020648

Trade/Device Name: Gridlock 195 Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Codes: DYH Dated: February 27, 2002 Received: February 28, 2002

Dear Dr. Steinberg:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device 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 Amendments, or to devices that have been reclassified in accordance 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 controls provisions of the Act include requirements for 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 your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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. of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Dr. Melvyn A. Steinberg

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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

Timothy Ulatowski

Timothy Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Usc

510(k) Number (if known): K020648

Device Name: GRIDOSH 195 (K020648)

Indications for Use:

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(Division Sign-Off) (Division Sign-Only)
Division of Dental, Infection Control,
Division of Dental, Infection Devices ... of Division of Delice Devicess 510(k) Number -

Prescription Usc (Per 21 CFR 801.109) Over-the-Counter Use _

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Regulation Number and Section

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.