Sureclear aligners

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the rest of the name in a sans-serif font. January 5, 2018 OraMetrix, Inc. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC. 1394 25th Street NW Buffalo, Minnesota 551313 Re: K171860 Trade/Device Name: Sureclear™ aligner system Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: December 27, 2017 Received: December 29, 2017 Dear Mark Job: 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. {1}------------------------------------------------ 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. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) Device Name sureclear™ aligners Indications for Use (Describe) Sureclear™ aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The font is sans-serif and the letters are evenly spaced. # 510(k) Summary ## OraMetrix sureclear™ aligners K #### 5.1 Submission Sponsor OraMetrix, Inc. 2350 Campbell Creek Blvd. Suite 400 Richardson, TX 75082 USA Phone number: 49-30-24309139 Contact: Sabrina Weitzel Email: sabrina.weitzel@orametrix.de #### 5.2 Submission Correspondent Emergo Global Consulting, LLC 2500 Bee Cave Road, Bldg. 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Contact: Stuart R. Goldman, Senior Consultant, RA Email: project.management@emergogroup.com #### 5.3 Date Prepared May 31, 2017 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Emergo. The logo consists of a red circular icon with three curved white lines inside, followed by the word "EMERGO" in black, sans-serif font. The logo is simple and modern, with a focus on the company name. #### 5.4 Device Identification | Trade/Proprietary Name: | sureclear™ aligners | |-------------------------|-----------------------------| | Common/Usual Name: | Sequential aligners | | Classification Name: | Orthodontic plastic bracket | | Regulation Number: | NXC | | Product Code: | 872.5470 | | Device Class: | Class II | | Classification Panel: | Dental | #### 5.5 Legally Marketed Predicate Device ClearCorrect System (K113618) #### 5.6 Device Description OraMetrix sureclear™ aligners are orthodontic aligners fabricated from a clear, thin thermoformed plastic in a sequential series, individually customized for each patient based on a doctor's prescription to progressively reposition the teeth via gentle, corrective forces in the upper and lower dental arches. The patient's dentist or orthodontist will use a digital scanning system to capture the anatomy and locations of the patient's teeth, and then after evaluating those will fill out an electronic prescription form describing the treatment plan using OraMetrix's previously cleared Suresmile® System software (K002620). The digitally scanned tooth data and prescription form are sent electronically via the Suresmile System® to OraMetrix technicians, using the Suresmile® System, separate the tooth scan data into individual tooth models representing the patient's malocclusion. Additional OraMetrix technicians, also using the Suresmile® System's software, interpret the doctor's instructions provided on the prescription form; produce a setup and a sequence of intermediate models corresponding to each stage of the patient's aligner therapy. The setup and the intermediate stages are sent, via the Suresmile® System, back to the doctor for review, modification or approval. Once the doctor is satisfied with the planned therapy, an order for the production, packaging and shipment of the aligners is made via the Suresmile® System. #### 5.7 Indication for Use Sureclear™ aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Emergo. The logo consists of a red circular icon with three curved white lines inside, followed by the word "EMERGO" in black, sans-serif font. The logo is simple and modern. ### 5.8 Substantial Equivalence Discussion OraMetrix has chosen the ClearCorrect System cleared by the FDA under K113618 as the predicate device for its sureclear™ aligners. The following table compares the subject device to the predicate device with respect to their indications for use, technology and performance testing, thus demonstrating the basis for determination of substantial equivalence between these devices. | Regulatory Information | | | | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------| | Device Name | Sureclear™ Aligners | ClearCorrect System | Similarities/<br>Differences | | Manufacturer | OraMetrix, Inc. | ClearCorrect, Inc. | na | | 510(k) | Pending | K113618 | na | | Product Code | NXC | NXC | Same. | | Regulation | §872.5470 | §872.5470 | Same. | | Class | II | II | Same. | | Indications for<br>Use | Sureclear™ aligners are indicated for<br>the treatment of tooth malocclusion<br>in patients with permanent dentition. | The ClearCorrect System is indicated for<br>the treatment of tooth malocclusion in<br>patients with permanent dentition (i.e.,<br>all second molars). The ClearCorrect<br>System positions teeth by way of<br>continuous gentle force. | Same. | | Prescription use | Yes | Yes | Same. | | Fundamental Scientific Technology | | | | | Device Images | Image: Sureclear Aligners | Image: ClearCorrect Aligners | Similar. Varies<br>by patient<br>prescription. | | Conditions of<br>Use | Worn daily by the patient for<br>approximately 20 to 22 hours, except<br>when performing dental hygiene and<br>eating and drinking. The treatment<br>plan (and time) varies by individual<br>patient prescription. | Worn daily by the patient for<br>approximately 20 to 22 hours, except<br>when performing dental hygiene and<br>eating and drinking. The treatment plan<br>(and time) varies by individual patient<br>prescription. | Same. | #### Table 5-1 – Comparison of Characteristics {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the Emergo logo. The logo consists of a red circular icon with three curved white lines inside, followed by the word "EMERGO" in black, sans-serif font. The logo is simple and modern, with a focus on the company name. | Mechanism of<br>Action | Sequential aligners are made from<br>elastic thermoplastic materials that<br>apply continuous gentle force to the<br>teeth. | Sequential aligners are made from<br>elastic thermoplastic materials that<br>apply continuous gentle force to the<br>teeth. | Same. | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------| | Material | Elastic thermoplastic material. | Elastic thermoplastic material. | Similar. | | Sizes | Patient specific. | Patient specific. | Same. | | Manufacturing<br>method | Thermoforming. | Thermoforming. | Similar. | | Body Location | Mouth; mucosal membranes. | Mouth; mucosal membranes. | Same. | | Relevant Testing Performed | | | | | Biocompatibility<br>Testing | Per ISO 10993-1 and applicable parts. | Per ISO 10993-1 and applicable parts. | Similar. | | Animal Testing | Not required and not performed. | Not required and not performed. | Same. | | Clinical Testing | Not required and not performed. | Not required and not performed. | Same. | | Risk Analysis | Per ISO 14971. | Assumed to have been performed. | Similar. | ### 5.9 Non-Clinical Performance Data OraMetrix has submitted finished sureclear™ aligners for the appropriate biocompatibility testing per ISO 10993-1 and its applicable parts, while the physical and mechanical properties of the elastic thermoplastic materials used to fabricate the aligners have previously been demonstrated by the manufacturer of the base materials. The subject device meets all internal OraMetrix specification requirements to support substantial equivalence to the predicate device. #### 5.10 Clinical Performance Data The performance of sequential aligners in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. Therefore, there was no clinical testing required to support sureclear™ aligners, as the indications for use is equivalent to the predicate device, which was not subjected to any clinical testing. The substantial equivalence of the subject device to the ClearCorrect System is supported by the non-clinical testing that was performed, along with other supporting documentation, and presented in this submission. #### 5.11 Statement of Substantial Equivalence Sureclear™ aligners have substantially equivalent Indications for Use as the identified predicate device. While the verbiage of the Indications of Use of the subject device is slightly different than the declared predicate; however, these slight differences do not alter the intended therapeutic use of the device as compared to the predicate device. The conclusions drawn from the data included in this submission, {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Emergo. The logo consists of a red circular icon with three curved lines inside, followed by the word "EMERGO" in black, sans-serif font. The logo is simple and modern, with a focus on the company name. demonstrate that sureclear™ aligners are as safe, as effective, and are substantially equivalent to the predicate device in indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility.