(328 days)
Not Found
No
The description focuses on the material composition and physical properties of PMMA discs used in traditional CAD/CAM milling, with no mention of AI/ML algorithms for design, processing, or analysis.
No
Explanation: This device is used for the fabrication of temporary crowns and bridges, which are restorative dental components, not therapeutic treatments.
No
This device is described as PMMA CAD/CAM discs used for the "fabrication of temporary crowns and bridges," which are restorative dental products, not diagnostic tools. The description focuses on its material composition and use in milling machines by dental technicians for fabrication purposes.
No
The device description clearly states it is composed of physical materials (PMMA) and is a blank used in milling machines, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fabrication of temporary crowns and bridges." This is a manufacturing process for a dental prosthetic, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is a "PMMA CAD/CAM disc," which is a material used in a milling machine to create a physical object. It's a raw material for fabrication.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting substances, or providing information for diagnosis, monitoring, or screening.
- Anatomical Site: While the final product (crowns and bridges) is used in the mouth, the device itself is a material used in a lab setting.
- Performance Studies: The performance studies mentioned are related to biocompatibility (cytotoxicity, sensitization, irritation), which are relevant for materials that will be in contact with the body, but not indicative of diagnostic performance.
IVD devices are specifically designed to perform tests on samples from the human body (like blood, urine, tissue) to provide information for medical diagnosis or treatment decisions. This device is a material used in a manufacturing process for a dental restoration.
N/A
Intended Use / Indications for Use
- fabrication of temporary crowns and bridges.
Product codes (comma separated list FDA assigned to the subject device)
EBG
Device Description
PMMA CAD/CAM discs are blanks used in different milling machines (dental CAD-CAM systems) by professional dental technicians. They are composed of hot cured polymethyl methacrylate (PMMA) and pigments. Device is available in A1, A2, A3, B1, B2, B3, BL3 and clear shades. Discs of all shades are available in different dimensions (diameter, thickness and profile margin).
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
professional dental technicians
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)
Cytotoxicity, sensitization and irritaton testing was conducted on PMMA CAD/CAM discs.
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
KII2967
PoliDent ഇ
AUG 28 8 2012
Polident d.o.o. Dental Products Industry Volčja Draga 42 5293 Volčja Draga Telephone: 00386 5 3304840, Fax: 00386 5 3304870 SLOVENIJA
Title 5: 510(k) Summary
510(k) owner's name:
Polident d.o.o. Dental Products Industry Volčja Draga 42 5293 Volčja Draga Slovenija Phone: 00386-53304840 Fax: 00386-53304870
Contact person:
mag. Janja Lipušček Phone: 00386-53304859 e-mail: janja.lipuscek@polident.si
Date of summary:
Trade name:
Classification name: Product code: Regulation number: Device class:
Temporary crown and bridge resin EBG 872.3770 ll
Legally marked equivalent device: 510(k) number:
ZENO PMMA disc K080182
l
27th August, 2012
PMMA CAD/CAM DISC
1
Device description:
PMMA CAD/CAM discs are blanks used in different milling machines (dental CAD-CAM systems) by professional dental technicians.
They are composed of hot cured polymethyl methacrylate (PMMA) and pigments. Device is available in A1, A2, A3, B1, B2, B3, BL3 and clear shades. Discs of all shades are available in different dimensions (diameter, thickness and profile margin).
Indications for Use:
- fabrication of temporary crowns and bridges. -
Summary of the technological characteristics compared to the predicate device:
Polident PMMA CAD/CAM discs are substantially equivalent to the dental device ZENO PMMA disc.
The proposed and predicate devices are both composed of polymethyl metacrylate 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. They have the same aesthetic function.
We can conclude that Polident PMMA CAD/CAM disc has comparible technological characteristics to the predicate device.
Substantial equivalence:
The proposed and predicate devices are both composed of polymethyl metacrylate hot cured polymer. Both devices have similar indications for use. The proposed and predicate devices have similar physical and chemical properties. Both devices have comparable e-modulus, flexural strength and deflection. The polymerization grade of both devices is high. They have the same aesthetic function.
Cytotoxicity, sensitization and irritaton testing was conducted on PMMA CAD/CAM discs.
Conclusion:
We are claiming substantial equivalence of PMMA CAD/CAM disc to the predicate device ZENO PMMA disc.
2
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is the department's logo, which is a stylized image of a person embracing another person.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Janja Lipušček Polident d.o.o., Dental Products Industry Volčja Draga 42 Volčja Draga Slovenia 5293
AUG 28 2012
Re: K112967 Trade/Device Name: PMMA CAD/CAM disc Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: August 20, 2012 Received: August 23, 2012
Dear Ms. Lipuscek:
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.
Page 2- Ms. Lipuscek
3
Page 2- Ms. Lipuscek
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Nh for
Anthony B. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
PoliDent
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Polident d.o.o. Dental Products Industry Volčja Draga 42 5293 Volčja Draga Telephone: 00386 5 3304840, Fax: 00386 5 3304870 SLOVENIJA
Title 4: Indications for Use Statement
510(k) Number (if known): K112967
Device Name: PMMA CAD/CAM disc
Indications For Use:
fabrication of temporary crowns and bridges -
Prescription Use: × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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