(44 days)
Not Found
None
No
The summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The intended use and device description (though not found) are typical for dental materials.
No
The intended uses are for core buildups and cementation of pins and posts, which are restorative dental procedures and not typically considered therapeutic.
No
The "Intended Use / Indications for Use" section describes the device for "Core buildups" and "Cementation of pins and posts," which are restorative and procedural uses, not diagnostic.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The intended use suggests a dental application, which could involve hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed ("Core buildups," "Cementation of pins and posts") are procedures performed directly on a patient's teeth, not on samples taken from the body for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting markers of disease, or providing diagnostic information.
- Anatomical Site: While not explicitly stated, the intended uses clearly point to the oral cavity, which is a direct application site, not a source of samples for in vitro analysis.
IVDs are devices used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's intended uses fall under the category of dental restorative materials and procedures, which are not IVDs.
N/A
Intended Use / Indications for Use
- Core buildups. ■
- . Cementation of pins and posts when used with suitable dentin adhesive.
Product codes
EBF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
MAR 0 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Janine Rauhut Quality Assurance & Regulatory Affairs Manager Dental Technologies, Incorporated 6901 North Hamlin Avenue Lincolnwood, Illinois 60712
Re: K070191
Trade/Device Name: Alpha-Core DC Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: January 10, 2007 Received: January 22, 2007
Dear Ms. Rauhut:
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.
1
Page 2 - Ms. Janine Rauhut
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. 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syette Y. Michael DMD.
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
110 7091 510(k) Number (if known):
Device Name: Alpha-Core DC
Indications for use:
- Core buildups. ■
- . Cementation of pins and posts when used with suitable dentin adhesive.
ISO 9001
Prescription Use V (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),
| DENTAL TECHNOLOGIES, INC.
6901 N. HAMLIN AVENUE
| LINCOLNWOOD, ILLINOIS 60712 USA | Page 14 of 157 |
|---|---|
| 1.800.835.0885 TOLL FREE [US/CANADA] | |
| 1.847.677.5500 PHONE | |
| 1.847.677.5502 FAX |
Susan Russpar