(43 days)
Not Found
Not Found
No
The summary describes dental restoration materials and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a light-cured resin material used for dental restorations, which is a structural material, not therapy.
No
Explanation: The Intended Use/Indications for Use states that this device is a light-cured/heat and pressure-cured resin material for the preparation of indirect inlay and onlay dental restorations. This describes a restorative material, not a device used to diagnose a medical condition.
No
The device is described as a light-cured and heat/pressure-cured resin material, which are physical substances, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the materials are for the preparation of indirect inlay and onlay dental restorations. This is a direct application within the mouth for restorative purposes.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis or monitoring.
- Device Description (or lack thereof): While the description is "Not Found," the intended use is the primary indicator.
- Other Sections: The absence of information in sections like "Mentions image processing," "Mentions AI, DNN, or ML," "Input Imaging Modality," "Anatomical Site," "Indicated Patient Age Range," "Intended User / Care Setting," and performance study details further supports that this is not a diagnostic device.
In summary, the function of these materials is to create dental restorations, which is a therapeutic/restorative purpose, not a diagnostic one.
N/A
Intended Use / Indications for Use
Concept HP Add-On is light cured resin material for the preparation of indirect inlay and onlay dental restorations
Concept HP Enamel is heat and pressure cured resin material to be used for the in indirect inlay and onlay dental restorations.
The materials are contraindicated for: Veneers Metal supported crown & bridges Metal Supporty cemented metal-free restorations Patients with occlusal dysfunction, parafunctions Patients with insufficient oral hygiene
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): 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" 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
JAN 2 1 2004
Ms. Donna M. Hartnett Director of Quality Assurance & Regulatory Affairs Ivovicar Vivadent, AG 175 Pineview Drive Amherst, New York 14228
Re: K033773
Trade/Device Name: Concept HP Add-On and Concept HP Enamel Regulation Number: 21 FR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 25, 2003 Received: December 12, 2003
Dear Ms. Hartnett:
This letter corrects our substantially equivalent letter of January 15, 2004 regarding the regulation name and number.
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 (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 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. Hartnett
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 continue 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 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Clur L
Chiu Lin, Ph.D. 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): K033773
Device Name: Concept HP Add-On and Concept HP Enamel
Indications For Use:
Concept HP Add-On is light cured resin material for the preparation of indirect inlay and onlay dental restorations
Concept HP Enamel is heat and pressure cured resin material to be used for the Oonocpt in Eindirect inlay and onlay dental restorations.
The materials are contraindicated for: Veneers Metal supported crown & bridges Metal Supporty cemented metal-free restorations Patients with occlusal dysfunction, parafunctions Patients with insufficient oral hygiene
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
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)
Susa Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
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510(k) Number: K033773