(14 days)
Not Found
Not Found
No
The summary describes a dental filling material and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is described as a "fluoride releasing temporary tooth filling or as a base cement to be applied in a tooth to protect the tooth pulp," which directly indicates a therapeutic purpose for treating or protecting teeth.
No
The device is described as a temporary tooth filling or base cement to protect the tooth pulp, indicating a therapeutic or protective function rather than a diagnostic one.
No
The description clearly states the device is a "temporary tooth filling or as a base cement," which are physical materials applied to a tooth, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "fluoride releasing temporary tooth filling or as a base cement to be applied in a tooth to protect the tooth pulp." This describes a device that is applied directly to the patient's tooth for a therapeutic or protective purpose.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens, including blood, urine, and tissue, taken from the human body to provide information for diagnosis, monitoring, or screening. They are used outside the body (in vitro).
The function of GI DentStat is clearly an in vivo application (within the living body), not an in vitro examination of specimens.
N/A
Intended Use / 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.
Product codes
EMA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)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.(2)
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 § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
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.
1
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 (800) 638-2041 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
2
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,
Page 1 o (Posted November 13, 20t