AA temp temporary restoration 3D printing photoreactive resin

{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 and 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. May 5, 2020 Enlighten Materials Co., Ltd % Chiao-Min Chang Regulatory Affairs Voler Biotech Consulting Co., Ltd. No. 3-1, Ln 58, Hejiang St., Zhongshan Dist., Taipei City, 10480 TAIWAN Re: K191590 Trade/Device Name: AA temp temporary restoration 3D printing photoreactive resin Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: March 29, 2020 Received: April 3, 2020 Dear Chiao-Min Chang: 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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 (OS) 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 mediation-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 "Nandu" Nandkumar, Ph.D. 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) K191590 #### Device Name AA temp temporary restoration 3D printing photoreactive resin #### Indications for Use (Describe) AA temp temporary restoration 3D printing photoreactive resin is a light-curable polymerizable resin to fabricate, by additive manufacturing, temporary crowns or bridges. The fabricated temporary crowns or bridges are an alternative to preformed temporary crowns or bridges and require digital models of crowns or bridges, a stereolithographic additive printer, and curing light equipment. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------|--------------------------------------------------------| | <div><span style="text-decoration: underline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Tel: (O) +886956973958 ## Device Name and Classification | Product Name: | AA temp temporary restoration 3D printing<br>photoreactive resin | | | | | | |-----------------------|-------------------------------------------------------------------|--|--|--|--|--| | Classification Name: | Temporary crown and bridge resin. | | | | | | | Common or Usual Name: | Dental Material | | | | | | | Classification Panel: | Dental Device | | | | | | | Regulation Number: | 872.3770 | | | | | | | Device Class: | Class II | | | | | | | Product Code: | EBG | | | | | | | Predicate Device | | | | | | | | Product Name: | K102776<br>e-DENT TEMPORARY RESIN and EXTRA-ORAL<br>CURING SYSTEM | | | | | | ## Device Description AA temp is a photosensitive resin intended for use to fabricate temporary crowns and bridges using CAD/CAM additive printing process. The AA temp polymer is a viscous solution of the following compounds: methacrylate-based resins, a photoinitiator that activates between 385nm to 405 nm light, and pigments. It comes in one size, one kilogram per bottle. It is compliant to the requirements defined in ISO 10477-2018 for Type 2 Class 2 materials. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printing, the printed product is placed in a UV-light curing box for final polymerization. 3D printer is not included with the device. {4}------------------------------------------------ ## Indications for Use AA temp temporary restoration 3D printing photoreactive resin is a light-curable polymerizable resin to fabricate, by additive manufacturing, temporary crowns or bridges. The fabricated temporary crowns or bridges are an alternative to preformed temporary crowns or bridges and require digital models of crowns or bridges, a stereolithographic additive printer, and curing light equipment. | | K191590 | K102776 Predicate Device | Differences | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | AA temp temporary<br>restoration 3D printing<br>photoreactive resin | e-dent Temporary<br>Resin and<br>EXTRA-ORAL<br>curing system | NA | | Indication for<br>use | AA temp temporary<br>restoration 3D printing<br>photoreactive resin is a<br>light-curable<br>polymerizable resin to<br>fabricate, by additive<br>manufacturing, temporary<br>crowns or bridges. The<br>fabricated temporary<br>crowns or bridges are an<br>alternative to preformed<br>temporary crowns or<br>bridges and require digital<br>models of crowns or<br>bridges, a<br>stereolithographic additive<br>printer, and curing light<br>equipment. | The e-DENT<br>TEMPORARY<br>resin is indicated<br>for the fabrication<br>of temporary<br>dental restorations<br>in conjunction<br>with extra-oral<br>light equipment. | Both devices are<br>acrylates or<br>methacrylates for<br>the fabrication<br>and repair of<br>temporary<br>crowns, bridges<br>and CAD/CAM<br>additive printing. | ## Comparison to Technology {5}------------------------------------------------ | | K191590 | K102776<br>Predicate Device | Differences | |-----------------------------------|-----------------------------------------|-----------------------------------------|------------------------------| | Acrylic Resin | Light- Cure Resin | Light- Cure Resin | Identical | | Chemical<br>Characterization | Methacrylate-<br>based resin | Methacrylate-<br>based resin | Methacrylate-<br>based resin | | Polymerization<br>(curing) Method | Visible light | Visible light | Identical | | Inorganic Filler | 0.49% | 49.8 % by weight | Non-Identical | | Product State | Pre-mix resin | Pre-mix resin | Identical | | Fabrication of<br>denture Base | CAD/CAM<br>additive printing<br>process | CAD/CAM<br>additive printing<br>process | Identical | | Teeth Assemble | Bonding | Bonding | Identical | ## Device Description K102776 contains 49.8% of inorganic fillers and K191590 contains 0.49% of inorganic fillers. Higher filler content can enhance the wear resistance and adjust the optical properties of a resin. Higher filler content, however, may decrease the flowability of the resin and can possibly decrease the degree of conversion after light-curing. According to the physical properties table of the K191590 below, its lower filler content does not affect its flexural strength, water absorption and solubility. Moreover, K191590 also comply with all biocompatibility tests. Therefore, the difference in filler content will not raise concern of the safety and effectiveness. ## Physical properties | | K191590 | K102776 | Difference | |-------------------|-------------------------------|-------------------------------|------------| | | | Predicate Device | | | Flexural Strength | >100MPa | >100MPa | Identical | | Water Absorption | Complies with En<br>ISO 10477 | Complies with En<br>ISO 10477 | Identical | | Solubility | Complies with En<br>ISO 10477 | Complies with En<br>ISO 10477 | Identical | ## Non-clinical performance testing Chemical Test {6}------------------------------------------------ - Test for Heavy Metals USEPA 3052 method. - ## Biocompatibility Testing The biocompatibility evaluation for AA temp temporary restoration 3D printing photoreactive resin was conducted in accordance with the FDA Blue Book Memorandum #G95 and international Standard ISO 10993-1. - Cytotoxicity - - Oral Mucosa Irritation Test - - Skin sensitization study (Maximization test) - - Acute Systemic Toxicity Study - - -Genotoxicity - ONLY Salmonella Reverse Mutation Test was completed. Other three tests, including (1) an in vitro test with cytogenetic of chromosomal damage with mammalian cells (OECD 473), (2) an in vitro mouse lymphoma TK assay (OECD 476), modified for medical devices, including detection of small (slow growing) and large colonies, and (3) an in vitro mammalian cell micronucleus test for chromosomal damage and aneugenicity (OECD 487) will be completed by the end of July 2020. ## Bench Testing - -ISO 10477. Dentistry-Polymer-based crown and bridge materials. 2018. - -Shelf life testing, AA TEMP has a shelf life of 2.5 years. The shelf testing has been conducted with the bench test from the ISO Standard 10477 and ISO 868. {7}------------------------------------------------ ### Similarity and differences Difference between the proposed device and predicate device is that this submission does not include Extra-ORAL CURING SYSTEM, only the Resin. K102776 contains 49.8% of inorganic fillers and K191590 contains 0.49% of inorganic fillers. Higher filler content can enhance the wear resistance and adjust the optical properties of a resin. Higher filler content, however, may decrease the flowability of the resin and can possibly decrease the degree of conversion after light-curing. According to the physical properties table of the K191590 below, its lower filler content does not affect its flexural strength, water absorption and solubility. Moreover, K191590 also comply with all biocompatibility tests. Therefore, the difference in filler content will not raise concern of the safety and effectiveness. ## Conclusion Based on similarities in technology and indications for use, as well as results of nonclinical performance testing, AA temp temporary 3D printing photoreactive resin is substantially equivalent to the predicate device.