(114 days)
Not Found
No
The 510(k) summary describes a material (PMMA discs) for use in CAD/CAM systems, not the CAD/CAM system itself. There is no mention of AI or ML in the description of the material or its testing.
No.
The device is a PMMA blank used to mill long-term temporary substructures for crowns and bridgework, which are restorative dental materials, not therapeutic devices.
No
Explanation: The device is a material (polymethylmethacrylate blanks) used to mill temporary substructures for crowns and bridgework in dental CAD/CAM systems. It does not perform any diagnostic function.
No
The device is a physical material (PMMA discs) used in dental CAD/CAM systems, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for milling long-term temporary substructures for crowns & bridgework using CAD/CAM systems. This is a dental restorative application, not a diagnostic test performed on biological samples.
- Device Description: The device is described as polymethylmethacrylate (PMMA) discs or blanks for use in dental CAD/CAM systems. This is a material used in the fabrication of dental prosthetics.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on physical, chemical, and biological properties relevant to a dental material in contact with the patient, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to be shaped into a dental prosthetic component.
N/A
Intended Use / Indications for Use
ARGEN PMMA Discs are polymethylmethacrylate blanks for dental use. These blanks are used to mill long-term temporary substructures for crowns & bridgework. The blanks are intended to be used in various CAD/CAM systems.
Product codes (comma separated list FDA assigned to the subject device)
EBG
Device Description
Polymethylmethacrylate (PMMA) discs or blanks for use in dental CAD/CAM systems.
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)
Physical testing was conducted, concluding that ARGEN PMMA discs are substantially equivalent to the listed dental devices.
Biological testing was conducted in accordance with ASTM F895-84:1984, ISO 10993.5:1999, and US Pharmacopeia XXVIII. The material is considered non-toxic and has the same biological performance as substantially equivalent Dental Acrylic teeth.
Key results: The proposed and predicate devices are both composed of polymethylmethacrylate, a hot cured polymer, and have similar indications for use. They have similar physical and chemical properties, comparable e-modulus, flexural strength, and deflection. The polymerization grade of both devices is high, and they have the same aesthetic function.
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.
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
§ 872.3770 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
JUL 3 1 2014
Alloy Makers To The World
Image /page/0/Picture/3 description: The image shows the logo and contact information for The Argen Corporation. The logo features a stylized letter "A" in bold, black font, with the word "ARGEN" appearing to the right of the "A". Below the logo, the text provides the company's address as 5855 Oberlin Drive, San Diego, CA 92121-4718, United States of America. The telephone number is (858) 455-7900, and the fax number is (858) 626-8686.
510(k) Summary
Submitted by:
The Argen Corporation 5855 Oberlin Drive, San Diego, CA 92121 (858) 455-7900 x471 (PHONE), (858) 626-8686 (FAX)
Contact person: Craig Jolicoeur
Date prepared: 4/02/2013
Trade name: ARGEN PMMA Common name: PMMA Resin Classification name: Temporary Crown and Bridge Material (21 CFR 872.3770 Product Codes EBG, ELM)
Legally marketed devices for which our organization is claiming substantial equivalence:
| 510(k)
| Number | Trade Name | Manufacturer |
|---|---|---|
| K102341 | VIPI Block | VIPI INDUSTRIA, COMERCIO, |
| EXPORTACAO E | ||
| IMPORTACAO DE | ||
| K071548 | WIELAND ZENO CAO TEMPORARY | |
| PMMA DISC, TOOTH-COLORED | MERZ DENTAL GMBH | |
| K061809 | EGRAL IMCROWN | MERZ DENTAL GMBH |
| K060293 | TEMPORARY CROWN AND BRIDGE | |
| MATERIAL | DENTSPLY INTERNATIONAL. | |
| INC. |
Device Description: Polymethylmethacrylate (PMMA) discs or blanks for use in dental CAD/CAM systems.
Intended Use: ARGEN PMMA Discs are polymethylmethacrylate blanks for dental use. These blanks are used to mill long-term temporary substructures for crowns & bridgework. The blanks are intended to be used in various CAD/CAM systems.
Predicate devices: K071548, K061809, K060293.
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Summary of the physical testing conducted on the device:
ARGEN PMMA discs are substantially equivalent and/or identical ' to the dental devices listed above.
The proposed and predicate devices are both composed of polymethylmethacrylate. A hot cured polymer, and have similar indications for use. The proposed and predicate devices have similar physical and chemical properties. The polymerization grade of both devices is high. In addition, they have the same aesthetic function.
We can conclude that ARGEN PMMA discs have comparable technological characteristics to the predicate device.
Summary of the biological testing conducted on the device:
Although this device comes into direct contact with the patient, the material is considered to be non-toxic. The material was tested in accordance with ASTM F895-84:1984. ISO 10993.5:1999 and US Pharmacopeia XXVIII.
PMMA resin continues to be the universal versatile polymer in denture dentistry.
The Acrylic PMMA block has the same biological performance as substantially equivalent Dental Acrylic teeth.
Substantial equivalence:
The proposed and predicate devices are composed of a polymethyl metacrylate hot cured polymer. All devices have similar indications for use. The proposed and predicate devices have similar physical and chemical properties. All devices have comparable e-modulus, flexural strength and deflection. The polymerization grade of both devices is high. And they have the same aesthetic function.
Conclusion:
We are claiming substantial equivalence of the ARGEN PMMA disc to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized symbol that resembles a person embracing another person, representing the department's mission of protecting the health of all Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
July 31, 2014
The Argen Corporation Mr. Craig Jolicoeur Quality & Regulatory Manager 5855 Oberlin Drive San Diego, CA 92121-4718
Re: K140894
Trade/Device Name: ARGEN PMMA Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: May 2, 2014 Received: May 5, 2014
Dear Mr. Jolicoeur:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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Page 2 - Mr. Jolicoeur
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for The Argen Corporation, a company that makes alloys. The logo features a stylized letter 'A' with the company name written across it. The company's address is 5855 Oberlin Drive, San Diego, CA 92121-4718, United States of America. The phone number is (858) 455-7900, and the fax number is (858) 626-8585.
Indications for Use Statement
510(k) Number (if known):
Device Name: ARGEN PMMA
Indications For Use:
ARGEN PMMA Discs are polymethylmethacrylate blanks for dental use. These blanks are used to mill long-term temporary substructures for crowns & bridgework. The blanks are intended to be used in various CAD/CAM systems.
Prescription Use X
(Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use _ · (21 CFR 807 Subpart C)