Portux CAD/CAM Disc

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November 7, 2019 New Stetic S.A. % Chris Brown Manager Aclivi Consulting 6455 Farley Road Pinckney, Michigan 48169 Re: K192153 Trade/Device Name: Portux CAD/CAM Disc Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG, EBI, MQC Dated: July 17, 2019 Received: August 9, 2019 Dear Chris Brown: 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/cfpmn/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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192153 Device Name Portux CAD/CAM Disc Indications for Use (Describe) For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics. - Provisional anterior and posterior crowns & bridges - Implant and abutment supported prosthetics. - Partial, complete and hybrid denture prosthetics (base and teeth) Removable appliances (splint) Type of Use (Select one or both, as applicable) | <span style="font-size:10pt"><span style="font-family:Wingdings">X</span></span> Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size:10pt">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Portux CAD/CAM Disc K192153 11/5/2019 #### 5.1 ADMINISTRATIVE INFORMATION | Manufacturer Name | New Stetic S.A.<br>Carrera 53 No. 50 - 09<br>Guarne – Antioquia<br>Colombia<br>Telephone: +57 4 550 00 00<br>Fax: +57 4 551 31 34 | Official Contact | Juan David Jaramillo G. - General Manager | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------------------------------| | Email: | infocolombia@newstetic.com | | | #### 5.2 DEVICE NAME AND CLASSIFICATION | Trade/Proprietary Name: | Portux CAD/CAM Disc | |-------------------------|----------------------------------| | Common Name: | Crown And Bridge, Temporary Resi | | Regulation Name: | Temporary Crown And Bridge Resin | | Regulation Number: | 21 CFR 872.3770 | | Device Class: | Class II | | Product Code: | EBG, EBI, MQC | | Classification Panel: | Dental Products Panel | | Reviewing Branch: | Dental Devices Branch | #### PREDICATE DEVICE INFORMATION 5.3 The devices within this submission are substantially equivalent in indications, intended use and design principles to the following Primary Predicate device: | 510(k) | Primary Predicate Device Name | Company Name | |---------|-------------------------------|------------------------------| | K180578 | Harvest Dental Polymer Blocks | Harvest Dental Products, LLC | #### DEVICE DESCRIPTION 5.4 The Subject device are discs made of poly methyl methacrylate (PMMA), a known material used in the dental field due their physical-chemical and biocompatibility properties. These discs are intended use with dental CAD/CAM equipment to produce a variety of provisional prosthetic restorations or devices. The discs are available in a variety of disc configurations to accommodate different commercial dental CAD/CAM machines fixture requirements. In addition, the CAD/CAM discs are available in a wide variety of heights and colors to facilitate matching of patient tooth or tissue shades. {4}------------------------------------------------ #### 5.5 INDICATIONS FOR USE For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics. - Provisional anterior and posterior crowns & bridges - Implant and abutment supported prosthetics. - Partial, complete and hybrid denture prosthetics (base and teeth) Removable appliances (splint) #### 5.6 EQUIVALENCE TO MARKETED DEVICE The comparison table below compare the Indications for Use and technological characteristics of the Subject and Primary Predicate devices. | Parameter | Subject Device | Primary Predicate Device | Equivalence Discussion | |--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | | Portux CAD/CAM Disc<br>(K192153)<br>New Stetic S.A. | Harvest Dental Polymer Blocks<br>(K180578)<br>Harvest Dental Products, LLC | | | Regulation Number | 21 CFR 872.3770 | 21 CFR 872.3770 | Substantially Equivalent | | Regulatory Class | Class II | Class II | Substantially Equivalent | | Product Code | EBG, EBI, MQC | EBG, EBI, MQC | Substantially Equivalent | | Indication for Use | For the fabrication of crowns, bridges<br>and structures for implant supported<br>provisional removable denture and<br>appliance prosthetics.<br>- Provisional anterior and posterior<br>crowns & bridges<br>- Implant and abutment supported<br>prosthetics.<br>- Partial, complete and hybrid denture<br>prosthetics (base and teeth) -<br>Removable appliances (splint) | For the fabrication of crowns, bridges<br>and structures for implant supported<br>provisional removable denture and<br>appliance prosthetics.<br>- Provisional anterior and posterior<br>crowns & bridges<br>- Implant and abutment supported<br>prosthetics.<br>- Partial, complete and hybrid denture<br>prosthetics (base and teeth) -<br>Removable appliances (splint) | Substantially Equivalent | | Technology | Blank for dental CAD/CAM | Blank for dental CAD/CAM | Substantially Equivalent | | Material Shades | VITA-shades, clear, pink, red | VITA-shades, clear, pink | Substantially Equivalent | | Material | PMMA | PMMA | Substantially Equivalent | | Biocompatible | Yes | Yes | Substantially Equivalent | | OTC or Rx | Rx | Rx | Substantially Equivalent | | Sterile | Non-sterile | Non-sterile | Substantially Equivalent | | Chemical Composition | | | | | Base Material | Polymethyl methacrylate | Polymethyl methacrylate | Substantially Equivalent | | Coloring Oxides | < 0.5% | < 1.1% | Substantially Equivalent | | Physical Properties | | | | | Performance Testing | ISO 10477<br>ISO 20795 | ISO 10477<br>ISO 20795 | Substantially Equivalent | | Flexural Strength | > 65 MPa | > 90 MPa | Substantially Equivalent<br>Slightly different values<br>doesn't affect intended<br>use of the device. | | | ISO 10477 ≥50 MPa<br>ISO 20795 ≥65 MPa | | | | Flexural Modulus | > 2000 MPa | > 2200 MPa | Substantially Equivalent<br>Slightly different values<br>doesn't affect intended<br>use of the device. | | | ISO 20795 ≥2000 MPa | | | | Water Absorption | ≤32 µg/mm³ | 24 µg/mm³ | Substantially Equivalent<br>Slightly different values<br>doesn't affect intended<br>use of the device. | | | ISO 10477 ≤40 µg/mm³<br>ISO 20795 ≤32 µg/mm³ | | | | Water Solubility | ≤1.6 µg/mm³ | 0.0 µg/mm³ | Substantially Equivalent<br>Slightly different values<br>doesn't affect intended<br>use of the device. | | | ISO 10477 ≤7.5 µg/mm³<br>ISO 20795 ≤1.6 µg/mm³ | | | | Residual monomer content | ≤2.2 % | < 1.1% | Substantially Equivalent<br>Slightly different values<br>doesn't affect intended<br>use of the device. | | | ISO 20795 ≤2.2% | | | {5}------------------------------------------------ Minor differences in material properties do not alter or impact the ability of the Subject device to be used for its intended use. In all cases, the Subject device meets the ISO 10477 and ISO 20795 material physical property requirements for these parameters. The Subject device is substantially equivalent to the Primary Predicate device with respect to Indications for Use and technological principles. #### 5.7 PERFORMANCE DATA Physical property testing was performed on the Subject device to ISO 10477:2018, Dentistry - Polymerbased crown and veneering materials and ISO 20795-1:2013, Dentistry - Base polymers - Part 1: Denture base polymers. Results are stated in the Substantial Equivalence Comparison table above demonstrating the Subject device meets the property requirements of the referenced standards. #### CLINICAL TESTING 5.8 The performance of PMMA as a provisional material in the clinical environment has been well established. No clinical testing was required to support substantial equivalence between the Subject and Primary Predicate devices. No clinical data is included in this submission. #### 5.9 BIOLOGICAL TESTING The Subject device was evaluated to the Irritation and Sensitization Biocompatibility Endpoints according to ISO 10993-10:2010/(R)2013 and evaluated for Cytotoxicity according to ISO 10993-5:2009. Test results demonstrate suitable biocompatibility for the Subject device. #### 5.10 CONCLUSION Overall, the Subject device has the following similarities to the legally marketed Primary Predicate device: - Has the same Indications for Use - Has the same Technological Characteristics - Is fabricated from the same material (PMMA) - Are both Prescription Use only - Supplied as non-sterile Therefore, the Portux CAD/CAM Disc Subject device is substantially equivalent to the Harvest Dental Polymer Blocks (K180578) Primary Predicate device.