(79 days)
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No
The summary describes a self-curing resin for dental restorations and contains no mention of AI or ML.
No
The device is a self-curing, cold-curing resin intended for fabricating dental restorations like crowns, bridges, inlays, and onlays, which are prosthetic devices, not therapeutic.
No
Explanation: The device, LEXATITE QUICK ACRYLIC, is described as a self-curing, cold-curing resin for dental restorations (crowns, bridges, inlays, and onlays). This indicates it is a material used in treatment or repair, not for diagnosing a condition.
No
The intended use describes a self-curing resin for dental restorations, which is a physical material, 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 it's a resin for creating dental restorations (crowns, bridges, inlays, onlays). This is a material used in the mouth for structural purposes, not for testing samples outside the body to diagnose or monitor a medical condition.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, based on the provided text, LEXATITE QUICK ACRYLIC is a dental material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
LEXATITE QUICK ACRYLIC is intended for use as a self-curing, cold-curing, resin for crowns, bridges, inlays and onlays.
Product codes
EBG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized symbol that represents human services. The symbol consists of three curved lines that resemble a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
Mr. J. Brad Vance Director of Regulatory Affairs & New Projects IMTEC Corporation 2401 N. Commerce Ardmore, Oklahoma 73401
Re: K033432
Trade/Device Name: Lexatite Quick Acrylic Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: September 29, 2003 Received: December 18, 2003
Dear Mr. Vance:
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 - Mr. Vance
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 (OS) 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 vour 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 (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Chih-Ling, Ph.D.
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
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K033432
Device Name: LEXATITE QUICK ACRYLIC Indications For Use:
LEXATITE QUICK ACRYLIC is intended for use as a self-curing, cold-curing, resin for LEAATTE QUORTAON crowns, bridges, inlays and onlays.
Prescription Use __ _________________________________________________________________________________________________________________________________________________________ AND/OR (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)
Susan Runge
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
(Division Con-Cir, Division of Anesthesionery Garleral Hospital, Infection Control. Deman Devroes
510(k) K033432