Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit

{0}------------------------------------------------ Figaro Crowns, Inc. Kyle Rose Quality Manager 1628 Ouail Ridge Circle Woodbury, Minnesota 55125 July 3, 2018 #### Re: K172952 Trade/Device Name: Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: March 30, 2018 Received: April 3, 2018 Dear Kyle Rose: 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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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 mediation-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, # Mary S. Runner -S 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) K172952 #### Device Name Figaro Crowns Anterior Crown Kit Figaro Crowns Posterior Crown Kit Indications for Use (Describe) The Figaro Preformed Dental Crown is intended for restoration of permanent teeth with a single unit crown. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------------|--| | <div style="display:flex; align-items:center;"> <input checked="" type="checkbox"/>Prescription Use (Part 81 CFR 201 Subpart D) </div> | | | <div style="display:flex; align-items:center;"> <input type="checkbox"/>Over-The-Counter Use (81 CFR 201 Subpart C) </div> | | > Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 5. 510(k) Summary K172952 Date of Preparation: 30-Mar-2018 # Attn: Figaro Crowns, Inc. 1628 Quail Ridge Circle Woodbury, MN USA 55125 %Kyle Rose Tel: 404.717.9358 Email: rookqualitysytems@gmail.com Official Contact: Kyle Rose Quality Manager ### Trade Name: Figaro Crowns Anterior Crown Kit Figaro Crowns Posterior Crown Kit Common Name: Dental material, filling/restorative, polymer based Classification Name: Tooth Shade Resin Material Classification Regulations: 21 CFR 872.3690 Product Code EBF Classification: Class II Predicate Device: K143694 Rhondium One-Visit-Crown (OVC) ### Device Description: The Figaro Crown is a permanent preformed resin crown used on adult patients. The crown is designed for permanent (>30 days) tooth restoration to restore, size, strength, chewing ability and for to improve appearance. The preformed crowns are manufactured to specific sizes for improved fit. The crowns go through a finishing {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Figaro Crowns. The logo features a green mountain range with three peaks, with a blue line forming the shape of a tooth above the mountains. Below the mountain range, the word "FIGARO" is written in a serif font, and below that, the word "CROWNS" is written in a sans-serif font. process and are not intended to the manipulated by the dentist. Sizing is exclusively determined by the dentist for each crown and patient. The crown is secured to the patient's mouth with standard adhesion techniques. Once the crown is cemented in place it should fully encase the portion of the tooth that lies above the gum line. The Figaro Preformed crown is made of layers fiberglass held together by epoxy resin. Small amounts of Titanium Dioxide and Yellow Iron oxide are added for cosmetic affect. The crowns are designed for the following designs, Canine, Upper Premolar, Upper Molar, Lower Premolar, Lower Molar. The crowns are provided in one size. ### Indications for Use: The Figaro Crowns are intended for restoration of permanent adult teeth with a single unit crown. #### Environment of Use: The Figaro Crowns are available for prescription only and intended to be used by a licensed dental professional such as DDS or DMD. Not for use by the general public or OTC. #### Contradictions: None ### Substantial Equivalence Discussion of Comparison to Predicates: The Figaro Crowns are viewed as substantially equivalent to the predicate device based on the equivalencies listed below. #### Indications- The indication for use is identical to the predicate K143694 Rhondium One-Visit-Crown (OVC). #### Technology- The technology used to create the preformed resin crown is similar to the predicate. The Figaro Crown does not require any additional uncured custom layers and therefore poses less risk that the predicate. #### Materials- {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo for "Figaro Crowns". The logo features a green mountain range with three peaks, overlaid by a blue, stylized tooth shape. Below the mountain range, the word "FIGARO" is written in a bold, serif font. Underneath "FIGARO", the word "CROWNS" is written in a smaller, green, sans-serif font. The materials are similar cured resins that have been found to meet ISO 10993 requirements and thus can be substantially equivalent to the safety of the predicate. | | Figaro Crowns Preformed | Rhondium One-Visit-Crown | |-----------------------|----------------------------|----------------------------------| | Comparison | Dental Crown | (OVC) | | | Preformed single tooth | | | | crown for one visit | Preformed single tooth crown | | Crown Description | restoration | for one visit restoration | | | Adult Canine, Upper | | | | Premolar, Upper Molar, | | | | Lower Premolar, Lower | Upper and lower canines, | | Teeth to be restored | Molar. | premolars, and molars | | | | N=8 designs : | | | N=5 designs: | Upper Premolar, Upper Molar, | | | Canine, Upper Premolar, | Lower Premolar, | | | Upper Molar, Lower | Lower Molar | | Specific crown design | Premolar, Lower Molar. | Each in Left and Right designs | | | Each design provided in 1 | Each design provided in 6 sizes: | | Crown Sizes | size | XS, S, M, L, XL, XXL | | | Heat cured polymer | | | | composite resin reinforced | Light-cured polymer composite | | Crown material | with fiberglass | resin | # Non-clinical Performance Testing: We have performed a number of bench tests to demonstrate the Figaro Crowns perform with in the specifications. These tests included: - Flexural Strength ● - Flexural Modulus . - Tensile Strength ● - Tensile Modulus ● - Charpy Index ● {6}------------------------------------------------ # Substantial Equivalence Conclusion The Figaro Crowns and the predicate device have similar indications for use and intended use and provide a similar range of designs and sizes for restoration. Both devices are provided nonsterile for single use only.