Ensmile

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March 16, 2023 Ensmile Pvt Ltd Mirza Rehman Head of Firm Main Canal RD, No. 2 Block H Johar Town, Lahore 54000 PAKISTAN Re: K222619 Trade/Device Name: Ensmile Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: February 13, 2023 Received: February 13, 2023 Dear Mirza Rehman: 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 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, # Michael E. Adjodha -S Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K222619 Device Name Ensmile Indications for Use (Describe) Ensmile Dental Plastic Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion. Type of Use (Select one or both, as applicable) > 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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Above the word "ensmile" are two curved, yellow lines that resemble a smile. 510(k) Summary ### 510(k) SUMMARY Ensmile Pvt Ltd's Ensmile 510K Number: K222619 Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared #### COMPANY'S NAME AND ADDRESS Ensmile Pvt Ltd Main Canal RD, No. 2 Block H Johar Town Lahore Pakistan 54000 Phone: +92 42 111 321 111 Contact Person: Mirza Gohar Rehman Date Prepared: March 16, 2023 #### Name of Device and Name/Address of Sponsor | Name of Device: | Ensmile | |-----------------------|----------------------------------------------------------------------| | Common or Usual Name: | Dental Plastic Aligners | | Classification Name: | Orthodontic Plastic Brackets - Sequential Aligners (21 CFR 892.5470) | | Regulatory Class: | II | | Product Code: | NXC | #### Primary Predicate Devices | Invisalign System | K081960 | |------------------------|---------| | Align Technology, Inc. | | #### Intended Use / Indications for Use The Ensmile is intended to be used for the alignment of teeth during orthodontic treatment of malocclusion. The Ensmile is indicated for use in alignment of teeth during orthodontic treatment of malocclusion. #### Technological Characteristics The Ensmile Aligners that are produced have the same technological characteristics as the primary predicate device, in that all the devices are made from commercially available plastic that is thermoformed to create a customized, patient-specific aligners are then used for minor tooth movement by way of continuous gentle force. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Ensmile Invisible Dental Aligners. The logo features two curved yellow lines above the word "ensmile" in blue. Below "ensmile" is the text "Invisible Dental Aligners" in a smaller blue font. The logo is simple and modern, with a focus on the brand name and product. Ensmile Pvt Ltd 510(k) Summary In both devices, the aligners are created by thermoforming commercially available plastic material. The Ensmile Aligners are thermoformed by Ensmile Pvt Ltd and in the case of the primary predicate device; the aligners are thermoformed by an outside laboratory. The Ensmile Aligner incorporates the use of attachments to create spaces and force points in order to cause minor tooth movement. These force points are located in specific areas and positioned in such a way that they provide a continuous force which slowly dissipates over time on the tooth to be moved for as long as the aligner is worn. #### Performance Data As part of demonstrating safety and effectiveness of Ensmile and in showing substantial equivalence to the primary predicate device that are subject to this 510(k) submission, Ensmile Pvt Ltd completed a number of non-clinical performance tests. Ensmile meets all the requirements for overall design, biocompatibility, and performance results confirming that the design output meets the design inputs and specifications for the device. Ensmile passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device: - Biocompatibility testing per ISO 10993-1 passed cytotoxicity, sensitization, irritation, Acute Systemic Toxicity, Mutagenicity, and Subacute Toxicity for the used thermoforming sheets. - Process Flow validation was performed to ensure that the finished device matches the software output specifications. The output and work model and aligner were tested and compared. Aligners met the specifications of this testing. In all instances, the Ensmile functioned and Biocompatibility Testing, and Process Flow Validation observed was as expected. | Feature | Proposed Device<br>Ensmile | Primary Predicate Device<br>Invisalign System | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | K222619 | K081960 | | Manufacturer | Ensmile Pvt Ltd | Align Technology, Inc. | | Regulation<br>Number | 21 CFR 872.5470 | 21 CFR 872.5470 | | Device<br>Classification<br>Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket | | Product Code | NXC | NXC | | Device Class | Class II | Class II | | Indications for<br>Use | Ensmile is indicated for the alignment<br>of teeth during orthodontic treatment<br>of malocclusion. | The Invisalign System is indicated for<br>the alignment of teeth during<br>orthodontic treatment of malocclusion. | | Feature | Proposed Device | Primary Predicate Device | | K Number | Ensmile<br>K222619 | Invisalign System<br>K081960 | | Device Description | The <b>Ensmile</b> is a sequence of<br>transparent aligners created from a<br>digital orthodontic treatment plan.<br>The <b>Ensmile</b> aligner is fabricated of a<br>transparent thermoformed<br>polyurethane plastic. Each aligner<br>delivery a unique combination of minor<br>forces to create the planned tooth<br>movement.<br>The digital orthodontic treatment plan<br>is created by a dental health<br>professional.<br>The <b>Ensmile</b> Aligner incorporates the<br>use of attachments to create spaces<br>and force points in order to cause<br>minor tooth movement. These force<br>points are located in specific areas and<br>positioned in such a way that they<br>provide a continuous force which<br>slowly dissipates over time on the tooth<br>to be moved for as long as the aligner is<br>worn. | The current Invisalign system is a series<br>of clear plastic aligners that are used to<br>replace traditional orthodontic wires<br>and brackets for the alignment of<br>maloccluded or misaligned teeth.<br>This series of aligners moves the teeth<br>gently, and in small increments, from<br>their original to their final treated<br>position for improved dental<br>alignment. | | Mode of<br>Action | Orthodontic tooth<br>movement occurs through<br>forces applied by the<br>appliance to the dentition<br>as each tooth follows the<br>programmed displacement<br>based on a doctor's<br>prescription | Orthodontic tooth<br>movement occurs through<br>forces applied by the<br>appliance to the dentition<br>as each tooth follows the<br>programmed displacement<br>based on a doctor's<br>prescription | | Anatomy Location | Mouth; mucosal | Mouth; mucosal | | Size | Patient specific | Patient specific | | Manufacturing<br>Method | Thermoforming | Thermoforming | | Material | Thermoplastic Polymer | Thermoplastic Polymer | | Material<br>Properties | Demonstrates sufficient<br>tensile strength, elasticity,<br>ductility, chemical resistance,<br>and clarity for use as a clear<br>tray aligner. | Demonstrates sufficient<br>tensile strength, elasticity,<br>ductility, chemical resistance,<br>and clarity for use as a clear<br>tray aligner. | | Software Used | Yes | Yes | | Feature | Proposed Device<br>Ensmile | Primary Predicate Device<br>Invisalign System | | K Number | K222619 | K081960 | | Workflow | | | | Design | Image: Ensmile aligner | Image: Invisalign aligner | #### Substantial Equivalence {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for "ensmile Invisible Dental Aligners". The logo features two curved yellow lines above the word "ensmile", which is written in blue. Below "ensmile" is the text "Invisible Dental Aligners", also in blue. Ensmile Pvt Ltd # 510(k) Summary {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for "ensmile Invisible Dental Aligners". The logo features two curved yellow lines above the word "ensmile", which is written in blue. Below "ensmile" is the text "Invisible Dental Aligners", also in blue. Ensmile Pvt Ltd ## 510(k) Summary Ensmile has the same intended uses and similar indications, technological characteristics, Manufacturing Method, Material Used and principles of operation as its primary predicate device. Ensmile is substantial equivalent to the Invisalign System. There are no differences between Ensmile and Invisalign System was defined therefore a performance testing was performed to Ensmile to ensure that patients are receiving the aligners as prescribed by the practitioner to move their teeth as intended (final position). The results of this performance testing are accepted according to acceptance criteria and do not raise any additional concerns. #### Conclusions Ensmile Aligners moves teeth by way of continuous gentle force through a sequence of clear aligners that follow the treatment plan developed by the clinician as does the primary predicate device, Invisalign System. The conclusions drawn from the data included in this submission, demonstrates that the Ensmile Aligner is substantially equivalent to the primary predicate devices cleared under premarket notification K081960 (Primary Predicate Device) in indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility.