GI DENTSTAT

K060334 · Ultradent Products, Inc. · EMA · Feb 23, 2006 · Dental

Device Facts

• Record ID: K060334
• Device Name: GI DENTSTAT
• Applicant: Ultradent Products, Inc.
• Product Code: EMA · Dental
• Decision Date: Feb 23, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GI DentStat serves as a fluoride releasing temporary tooth filling or as a base cement to be applied i a tooth to protect the tooth pulp.

Device Story

GI DentStat is a dental cement used by dental professionals as a temporary filling material or base cement for pulp protection. It functions by releasing fluoride into the tooth structure. The device is applied directly to the tooth in a clinical setting. It aids in restorative dental procedures by providing temporary coverage and pulp protection, potentially benefiting the patient by maintaining tooth integrity and reducing sensitivity during the interim period before permanent restoration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental cement (Product Code: EMA). Fluoride-releasing material. Formulated for temporary filling or base cement applications. Class II device per 21 CFR 872.3275(b).

Indications for Use

Indicated for use as a fluoride-releasing temporary tooth filling or as a base cement for tooth pulp protection in dental patients.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2006

Ms. Tammy Lavery Regulatory Affairs Senior Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095

Re: K060334

Trade/Device Name: GI DentStat Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: February 07, 2006 Received: February 09, 2006

Dear Ms. Lavery:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becales on (e) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } 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 provision in the 1977 by 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 n your as not is thee is ontrols. 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.

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## Page 2 - Ms. Tammy Lavery

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualice of a substance of a substance requirements of the Act of that FDA has made a determination mat your device relail agencies. You must comply with any Federal Statutes and regulations administered of out is istration and listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: registration all the Act s requirements, including, but not in in the manufacturing as set forth in the quality and other rediction labeling (21 CFR Part 801), good manazattang provinsable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic produc systems (QD) regalazes (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) I his letter will anow you to begin maneting of substantial equivalence of your everyits vour devi premarket notification. The FDA Inding of sucstantial view with the results your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Pat 801), please If you desire specific advice for your do not on the Also, please note the regulation entitled, contact the Office of Compliance at (210) 270 01.07.2017 Part 807.97). You may obtain other Missulanding by reference to promaintities under the Act from the Division of Small general informational on your responsibilities a.rater at its toll-free number [phone] or Manufacturers, International and Consulter Forstanter and consection industry/support/index.html.

Sincerely yours,

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): | K060334 |
|---------------------------|---------|
|---------------------------|---------|

GI DentStat Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

GI DentStat serves as a fluoride releasing temporary tooth filling or as a base cement to be applied i a tooth to protect the tooth pulp.

X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 801 CFR Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suror Reaser

Interny Ganersi Horpilal,

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