(134 days)
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Not Found
No
The summary describes a material (PMMA blocks) used in CAD/CAM milling for dental restorations. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The focus is on the material itself and its intended use in a manufacturing process.
Yes
The indications explicitly mention "removable structures for therapeutic restorations (bite splints or occlusal splints)".
No
The device is described as Evolux CAD/CAM PMMA Blocks, which are materials intended for making dental structures. Its function is to create physical dental appliances, not to diagnose medical conditions or provide diagnostic information.
No
The device described is a physical material (PMMA blocks) used in CAD/CAM milling, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that Evolux CAD/CAM PMMA Blocks are used for creating dental structures (crowns, bridges, dentures, splints) that are placed in the mouth, not for analyzing biological samples from the body.
- The device description focuses on the material and its application in dental fabrication. There is no mention of analyzing blood, urine, tissue, or any other bodily fluid or sample.
Therefore, this device falls under the category of a dental material used for fabrication, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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)
Product codes (comma separated list FDA assigned to the subject device)
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
Prescription Use (Part 21 CFR 801 Subpart D)
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): 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.
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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).
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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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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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