(134 days)
Evolux CAD/CAM PMMA Blocks are intended for making removable or temporary dental structures such as crowns and bridges using CAD/CAM milling technology.
Indications:
- Temporary anterior and posterior crowns
- Temporary anterior and posterior bridges with up to two adjacent pontics
- Implant supported temporary restorations
- Maximum recommended usage period: 12 months
- Removable structures for dentures (dental bases)
- Removable structures for therapeutic restorations (bite splints or occlusal splints)
Evolux CAD/CAM PMMA Blocks are intended for making removable or temporary dental structures such as crowns and bridges using CAD/CAM milling technology.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving device performance for the "Evolux Cad/cam Pmma Blocks". The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices, along with its indications for use. It does not include details of performance studies, sample sizes, expert qualifications, or ground truth establishment.
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December 13, 2018
Blue Dent Dental % Mauro Malzyner US Agent Passarini Regulatory Affairs of America, LLC Miami Center Building 201 South Biscayne Boulevard Suite 1200 Miami, Florida 33131
Re: K182065
Trade/Device Name: Evolux Cad/cam Pmma Blocks Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: November 14, 2018 Received: November 15, 2018
Dear Mauro Malzyner:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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.
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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Digitally signed by Mary S Mary S. F 1Vrail y 3. Date: 2018.12.13 11:22:14
Runner -S33 - Date: 2018.12.13 11:22:14
For Tina Kiang, Ph.D. Acting 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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Indications for Use
510(k) Number (if known) K182065
Device Name
Evolux CAD/CAM PMMA Blocks
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
Evolux CAD/CAM PMMA Blocks are intended for making removable or temporary dental structures such as crowns and bridges using CAD/CAM milling technology.
Indications:
- Temporary anterior and posterior crowns
- Temporary anterior and posterior bridges with up to two adjacent pontics
- Implant supported temporary restorations
- Maximum recommended usage period: 12 months
- Removable structures for dentures (dental bases)
- Removable structures for therapeutic restorations (bite splints or occlusal splints)
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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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.