(90 days)
The SmileAlign® Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The SmileAlign Orthodontic Aligner System positions teeth by way of continuous gentle force.
The SmileAlign® Orthodontic Aligner System is a series of dental aligners fabricated of clear, thin thermoformed polyethylene terephthalate glycol (PETG) plastic to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner.
This document describes the 510(k) premarket notification for the SmileAlign® Orthodontic Aligner System (K191774). However, it does not contain any information about an AI/Algorithm-driven device that would require an evaluation against specific acceptance criteria for algorithm performance, a test set, expert ground truth establishment, or clinical performance data related to AI assistance.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Byte Aligner System, K180346) based on material properties, indications for use, technological characteristics, and biocompatibility. It explicitly states: "Clinical data was not included in this submission."
Therefore, based on the provided text, I cannot fill in the requested table and information points regarding acceptance criteria and study data for an AI-driven device's performance, as this information is not present in the given FDA 510(k) summary.
The document describes the device as: "a series of dental aligners fabricated of clear, thin thermoformed polyethylene terephthalate glycol (PETG) plastic to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner." The only mention of software is that "Both the subject and predicate devices use independent dental software to translate tooth movements in developing the model schemes and allow the dental practitioner to review and approve the model schemes before aligner fabrication." This refers to standard CAD/CAM software used in the dental industry, not an AI algorithm performing diagnostic or treatment planning functions.
If this was a request for an AI-driven device, the provided text does not contain the necessary information.
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September 30, 2019
3D Global Biotech Inc. % Diana Lam Regulatory Affairs Consultant DuoCare, LLC 370 W Grand Blvd #110. Corona, California 92882
Re: K191774
Trade/Device Name: SmileAlign Orthodontic Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: July 2, 2019 Received: July 2, 2019
Dear Diana Lam:
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
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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
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Indications for Use
510(k) Number (if known) K191774
Device Name SmileAlign® Orthodontic Aligner System
Indications for Use (Describe)
The SmileAlign® Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The SmileAlign Orthodontic Aligner System positions teeth by way of continuous gentle force.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for 3D Global Biotech. The logo consists of the number "3" and the letter "D" in green, followed by the words "GLOBAL" and "BIOTECH" stacked on top of each other in gray. The logo is simple and modern, and the colors are eye-catching.
K191774 - 510(k) Summary
Applicant:
3D Global Biotech Inc.
Address: 21F-1, No.99, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City 221, Taiwan
Telephone: +886-2-26971270
Correspondent Contact:
Diana Lam,
DuoCare, LLC
Date Summary Prepared:
Semptember 30, 2019
DEVICE NAME: SmileAlign® Orthodontic Aligner System
TRADE NAME: SmileAlign® Orthodontic Aligner System
COMMON NAME: Aligner, Sequential
DEVICE CLASSIFICATION Name: Orthodontic Plastic Bracket
CLASSIFICATION REGULATION NUMBER: 21 CFR 872.5470 DEVICE CLASSIFICATION: CLASS II CLASSIFICATION PRODUCT CODE: NXC
Predicate Device
| Primary Predicate | Byte Aligner System | K180346 | Straight Smile, LLC |
|---|---|---|---|
| Reference Device | 3Shape Ortho System ™ | K152086 | 3Shape A/S |
Description of Device
The SmileAlign® Orthodontic Aligner System is a series of dental aligners fabricated of clear, thin thermoformed polyethylene terephthalate glycol (PETG) plastic to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner.
Indications for Use
The SmileAlign® Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The SmileAlign® Orthodontic Aligner System positions teeth by way of continuous gentle force.
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Image /page/4/Picture/0 description: The image contains the logo for Global Biotech. The logo has the number 3 in green on the left side of the image. To the right of the number 3 is the text "GLOBAL BIOTECH" in gray.
Substantial equivalence
The SmileAlign® Orthodontic Aligner System is substantially equivalent to the predicate device with respect to indications for use, technological characteristics, principles of operation and materials...... as demonstrated in the comparison table below.
| Item Name | Subject device | Predicate Device | SubstantialequivalenceAnalysis |
|---|---|---|---|
| Device name | SmileAlign® OrthodonticAligner System | Byte Aligner System | - |
| Manufacturer | 3D Global Biotech Inc. | Straight Smile, LLC | - |
| 510(K) No. | - | K180346 | - |
| RegulationNo. | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| ClassificationName | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket | Same |
| RegulatoryClass | Class II | Class II | Same |
| ProductCode | NXC | NXC | Same |
| Indicationsfor use | The SmileAlign® OrthodonticAligner System is indicated forthe treatment of toothmalocclusion in patients withpermanent dentition (i.e., allsecond molars). TheSmileAlign® OrthodonticAligner System positions teethby way of continuous gentleforce. | The Byte Aligner System isindicated for the treatmentof tooth malocclusion inpatients with permanentdentition (i.e., all secondmolars). The Byte AlignerSystem positions teeth byway of continuous gentleforce. | Same |
| IntendedPopulation | Individuals with permanentdentition | Individuals with permanentdentition | Same |
| Mode ofAction | Orthodontic tooth movementoccurs through forces appliedby the device to the dentitionas each tooth follows theprogrammed displacementbased on a doctor'sprescription. | Orthodontic tooth movementoccurs through forcesapplied by the device to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription. | Same |
| Mode of Use | Each aligner is worn by thepatient as determined by thetreating dental practitioner,generally for 2 weeks prior tobeing replaced by the nextaligner in sequence. This isrepeated for a duration asprescribed by a Dental | Each aligner is worn by thepatient as determined by thetreating dental practitioner,generally for 2 weeks priorto being replaced by thenext aligner in sequence.This isrepeated for a duration as | Same |
| Professional. | prescribed by a DentalProfessional. | ||
| Raw MaterialUsed | Thermoplastic polymers(polyethylene terephthalateglycol or PETG) | Thermoplastic polymers(polyethylene terephthalateglycol or PETG) | Same |
| OTC or Rx | Rx | Rx | Same |
| Design | Image: clear aligner | Image: clear aligner | Same |
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Image /page/5/Picture/0 description: The image shows the logo for 3D Global Biotech. The logo consists of the number "3" and the letter "D" in green, followed by the words "GLOBAL" and "BIOTECH" in gray. The words "GLOBAL" and "BIOTECH" are stacked on top of each other.
The SmileAlign® Orthodontic Aligner System is substantially equivalent to the predicate device. Both the subject and predicate devices use independent dental software to translate tooth movements in developing the model schemes and allow the dental practitioner to review and approve the model schemes before aligner fabrication. The difference between the subject and predicate device lies in the difference in manufacturer, where the risks have been mitigated by biocompatibility evaluation and material testing. SmileAlign® Orthodontic Aligner System uses 3Shape Ortho System™ (K152086), the reference predicate, as the software for dental professionals to generate and review model schemes.
Non-Clinical performance Data
Different biocompatibility tests in accordance with ISO10993 have been performed on the subject device. The results of these tests and studies indicate there is no evidence of any hazardous effects and the subject device is safe for its intended use.
| Test Name | Standard followed | Result |
|---|---|---|
| Cytotoxicity | ISO10993-5 | Pass |
| Irritation | ISO10993-10 | Pass |
| Sensitization | ISO10993-10 | Pass |
Material properties, such as tensile strength, compression strength, water absorption rate, density and pH change were tested, all results provided reasonable assurance of safety and effectiveness.
Clinical performance Data
Clinical data was not included in this submission.
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Image /page/6/Picture/0 description: The image contains the logo for 3D GLOBAL BIOTECH. The logo has the number "3D" in green on the left side of the image. To the right of the number "3D" is the text "GLOBAL BIOTECH" in gray.
www.3dqlobalbiotech.com.tw Tel: +886-2-26971270 Fax: +886-2-26971272
Conclusion
The SmileAlign® Orthodontic Aligner System has substantially equivalent Indications for Use and technological characteristics to the previously cleared predicate device Byte Aligner System (K180346). The conclusions drawn from the data included in this submission demonstrate that SmileAlign® Orthodontic Aligner System is substantially equivalent to the predicate devices in indications for use, design, technological characteristics, mode of action, method of use, performance, materials, and biocompatibility.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.