(90 days)
No
The summary describes a physical device (aligners) and its material properties, with no mention of AI/ML in the intended use, device description, or performance studies.
Yes
The device is indicated for the treatment of tooth malocclusion, which is a medical condition, making it a therapeutic device.
No
The device is described as an orthodontic aligner system used for treatment by repositioning teeth, and it does not mention any diagnostic capabilities or functions.
No
The device description explicitly states it is a "series of dental aligners fabricated of clear, thin thermoformed polyethylene terephthalate glycol (PETG) plastic," which are physical hardware components.
Based on the provided information, the SmileAlign® Orthodontic Aligner System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of tooth malocclusion by physically repositioning teeth. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a physical appliance (aligners) made of plastic that applies force to teeth. It does not involve analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic purpose.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SmileAlign system does not fit this definition.
N/A
Intended Use / 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.
Product codes
NXC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
patients with permanent dentition (i.e., all second molars)
Intended User / Care Setting
Dental Professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: Cytotoxicity, Standard followed: ISO10993-5, Result: Pass
Test Name: Irritation, Standard followed: ISO10993-10, Result: Pass
Test Name: Sensitization, Standard followed: ISO10993-10, Result: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
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
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 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
2
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) |
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
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.
4
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 | Substantial
equivalence
Analysis |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Device name | SmileAlign® Orthodontic
Aligner System | Byte Aligner System | - |
| Manufacturer | 3D Global Biotech Inc. | Straight Smile, LLC | - |
| 510(K) No. | - | K180346 | - |
| Regulation
No. | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Classification
Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket | Same |
| Regulatory
Class | Class II | Class II | Same |
| Product
Code | NXC | NXC | Same |
| 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. | The Byte Aligner System is
indicated for the treatment
of tooth malocclusion in
patients with permanent
dentition (i.e., all second
molars). The Byte Aligner
System positions teeth by
way of continuous gentle
force. | Same |
| Intended
Population | Individuals with permanent
dentition | Individuals with permanent
dentition | Same |
| Mode of
Action | Orthodontic tooth movement
occurs through forces applied
by the device to the dentition
as each tooth follows the
programmed displacement
based on a doctor's
prescription. | Orthodontic tooth movement
occurs through forces
applied by the device to the
dentition as each tooth
follows the programmed
displacement based on a
doctor's prescription. | Same |
| Mode of Use | Each aligner is worn by the
patient as determined by the
treating dental practitioner,
generally for 2 weeks prior to
being replaced by the next
aligner in sequence. This is
repeated for a duration as
prescribed by a Dental | Each aligner is worn by the
patient as determined by the
treating dental practitioner,
generally for 2 weeks prior
to being replaced by the
next aligner in sequence.
This is
repeated for a duration as | Same |
| | | | |
| | Professional. | prescribed by a Dental
Professional. | |
| Raw Material
Used | Thermoplastic polymers
(polyethylene terephthalate
glycol or PETG) | Thermoplastic polymers
(polyethylene terephthalate
glycol or PETG) | Same |
| OTC or Rx | Rx | Rx | Same |
| Design | Image: clear aligner | Image: clear aligner | Same |
5
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.
6
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.