(263 days)
No
The summary mentions image processing for generating and interpreting images of teeth states, but it does not explicitly mention the use of AI, ML, or related terms like deep learning or neural networks in the device description or performance studies.
Yes
The device is indicated for the "treatment of tooth malocclusion," which is a therapeutic purpose.
No
The device is an orthodontic aligner system used for repositioning teeth, which is a treatment, not a diagnostic, function. Its software uses scans to generate images of tooth states for treatment planning, not for diagnosing a condition.
No
The device description explicitly states it is a "series of dental aligners fabricated of clear, plastic removable aligners," which are physical hardware components. While software is used in the design process, the device itself is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- DailyMate Orthodontic Aligner System Function: The DailyMate system is a physical device (aligners) used to mechanically reposition teeth. It uses imaging and software to plan the treatment, but the core function is a physical intervention on the patient's teeth, not an analysis of a biological specimen.
- Intended Use: The intended use is "treatment of tooth malocclusion," which is a therapeutic intervention, not a diagnostic test performed on a specimen.
- Device Description: The description focuses on the physical aligners and the process of their fabrication and use for tooth movement.
- Input: The input is a scan of an impression or a digital scan of the teeth, which represents the physical structure of the teeth, not a biological specimen.
- Anatomical Site: The anatomical site is the teeth, which are being physically manipulated.
While the system uses imaging and software for planning, its primary function and intended use fall squarely within the realm of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DailyMate Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The aligner system repositions teeth by way of continuous gentle force.
Product codes
NXC
Device Description
The DailyMate® Orthodontic Aligner System is a series of dental aligners fabricated of clear, plastic removable aligners are designed and custom-made by dental professionals. The aligners are made of aesthetic and medical grade materials. 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 / tooth
Indicated Patient Age Range
patients with permanent dentition
Intended User / Care Setting
dental professionals / dental practitioner
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)
Bench tests using both the DailyMate® Orthodontic Aligner System and the Invisalign System were performed. The results of pH change test, water absorption change test and tensile strength change test showed that the DailyMate® Orthodontic Aligner System and the Invisalign System were substantial equivalent.
Biocompatibility testing for the aligner materials was completed in accordance with ISO 10993 per the following:
- Part 5: Cytotoxicity Test
- Part 10: Sensitization Test
- Part 10: Oral Mucosa Irritation Test
The testing results demonstrate that the material of DailyMate® Orthodontic Aligner System is biocompatible for the intended use.
A manufacturing validation report was also included to assure the substantial equivalence of the DailyMate® Orthodontic Aligner System.
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 & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
3D Global Biotech Inc % Diana Lam Regulatory Affairs Specialist 370 W Grand Blvd #110 Corona, California 92882
Re: K212803
Trade/Device Name: DailyMate Orthodontic Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: February 22, 2022 Received: February 22, 2022
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 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
1
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,
For 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) K212803
Device Name DailyMate Orthodontic Aligner System
Indications for Use (Describe)
The DailyMate Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The aligner system repositions teeth by way of continuous gentle force.
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.
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 contains the logo for 3D Global Biotech. The logo consists of the number "3D" in green on the left, and the words "GLOBAL BIOTECH" in gray on the right. The words "GLOBAL" and "BIOTECH" are stacked on top of each other.
510(k) Summary K212803
Applicant:
3D Global Biotech Inc.
- Address: 21F.-3, No.99, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City 221, Taiwan .
- Contact: Dr. Keng-Liang Ou, President .
- Telephone: +886-2-26971270
Correspondent Contact:
Diana Lam,
370 W. Grand Blvd, Suite 110, Corona, CA 92882
Date Summary Prepared:
May 6th, 2022
DEVICE NAME: DailyMate® Orthodontic Aligner System
TRADE NAME: DailyMate® 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 | SureCure Orthodontic
Aligner System | K182329 | Digital Orthodontic
Care |
|---------------------|----------------------------------------|---------|-----------------------------|
| Predicate | | | |
| Reference
Device | Invisalign System | K143630 | Align Technology, Inc. |
| Reference
Device | 3Shape Ortho SystemTM | K152086 | 3Shape A/S |
Indications for Use
The DailyMate® Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The aligner system repositions teeth by way of continuous gentle force.
Description of Device
4
Image /page/4/Picture/0 description: The image shows the logo for Global Biotech. The logo consists of a green stylized "3D" on the left, followed by the words "GLOBAL" and "BIOTECH" stacked on top of each other in gray. The "3D" is a stylized design, with the "3" and "D" connected.
The DailyMate® Orthodontic Aligner System is a series of dental aligners fabricated of clear, plastic removable aligners are designed and custom-made by dental professionals. The aligners are made of aesthetic and medical grade materials. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner.
Substantial equivalence
The DailyMate® Orthodontic Aligner System is substantially equivalent to the predicate device and the reference device with respect to indications for use, mechanism of action and materials...... as demonstrated in the comparison table below.
| Item Name | Subject device | Predicate Device | Predicate Device | Substantial
equivalence
Analysis |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Device name | DailyMate®
Orthodontic
Aligner System | SureCure
Orthodontic Aligner
System | Invisalign
System | |
| Manufacturer | 3D Global
Biotech Inc. | Digital Orthodontic
Care | Align
Technology, Inc. | |
| 510(K) No. | K212803 | K182329 | K143630 | - |
| Regulation
No. | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Classification
Name | Orthodontic
Plastic Bracket | Orthodontic Plastic
Bracket | Orthodontic
Plastic Bracket | Same |
| Regulatory
Class | Class II | Class II | Class II | Same |
| Product Code | NXC | NXC | NXC | Same |
| Indications
for
use/Intended
use | The DailyMate
Orthodontic
Aligner System is
indicated for the
treatment of tooth
malocclusion in
patients with
permanent
dentition. The
aligner system
repositions teeth
by way of
continuous gentle
force. | The SureCure
Orthodontic Aligner
System is indicated
for the treatment of
tooth malocclusion
in patients with
permanent dentition.
The aligner system
repositions teeth by
way of continuous
gentle force. | The Invisalign
System is indicated
for the alignment of
teeth during
orthodontic
treatment of
malocclusion | Same as the
predicate
device |
| Mechanism of
Action | Based on the
clinician's
treatment plan,
each aligner is
used for a
defined period of
time to exert | Based on the
clinician's treatment
plan, each aligner is
used for a defined
period of time to
exert gentle force to
achieve progressive | Sequential aligners
apply continuous
gentle force to the
teeth | Same |
| | gentle force to
achieve
progressive
realignment of
the teeth. This
occurs over time
until the final
correction has
been achieved. | realignment of the
teeth. This occurs
over time until the
final correction has
been achieved. | | |
| Method of
Use | Each preformed
plastic tray is
worn by the
patient as
prescribed by the
dental
practitioner,
usually a few
weeks prior to
using the next
sequential aligner
tray. | Each preformed
plastic tray is worn
by the patient as
prescribed by the
dental practitioner,
usually a few weeks
prior to using the
next sequential
aligner tray. | Aligners are worn for
approximately 2
weeks of 20-22
hours of wear per
day, after which it is
replaced by the next
stage aligners. This
is
repeated for duration
as prescribed by the
Dental
Practitioner | Same as the
predicate
device |
| Method of
Manufacture | Using software,
molds/models are
3D printed based
on the treatment
plan. Aligners
are fabricated on
the molds using a
thermoforming
machine. | Using software,
molds/models are
3D printed based on
the treatment plan.
Aligners are
fabricated on the
molds using a
thermoforming
machine. | The Align 3-D
Software uses a
scan of a PVS
impression
or a digital scan
(which represents
an untreated
state) to
generate the
image of a final,
treated state and
then interprets a
series of images
that represent
intermediate teeth
states. The dental
practitioner then
reviews these
images and has
the option to
reject or request
modifications to
the set-up prior to
approving it for
aligner
fabrication. Once
the dental
practitioner | Same as the
predicate
device |
| | | | approves the
treatment plan,
the software
converts the files
to produce the
series of custom-
made aligners | |
| Raw Material
Used | Thin
thermoformed
polyurethane | Thin thermoformed
polyurethane | Thin
thermoformed
polyurethane | Similar |
| OTC or Rx | Rx | Rx | Rx | Same |
| Software Use | 3Shape Ortho
System | 3Shape Ortho
System | Invisalign
System 3-D
software | Same as the
predicate
device |
| Sterilization | No | No | No | Same |
5
Image /page/5/Picture/0 description: The image contains a logo with the text "3D GLOBAL BIOTECH". The "3D" is in green, while "GLOBAL BIOTECH" is in gray. The "3D" is a stylized graphic, and the text is aligned horizontally.
6
Image /page/6/Picture/0 description: The image contains the logo for Global Biotech. On the left side of the logo is a green graphic that appears to be the number 3 with a circle attached to the right side of the number. To the right of the graphic is the text "GLOBAL BIOTECH" in gray. The text is stacked, with "GLOBAL" on top of "BIOTECH".
The DailyMate® Orthodontic Aligner System is substantially equivalent to the predicate device and the reference device. Both the subject and predicate devices use the same 510(k) cleared dental software 3Shape Ortho System (K152086) 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 bench tests using both the DailyMate® Orthodontic Aligner System and the Invisalign System were performed, the results of pH change test, water absorption change test and tensile strength change test showed that the DailyMate® Orthodontic Aligner System and the Invisalign System were substantial equivalent.
The differences among the subject device, the predicate device and the reference device lie in the variances in the aligner treatment plans which were customized for each individual patient. The associated risks have been mitigated by (1) A 510(k) requlated broadly recognized dental software, 3Shape Ortho System, is used for aligner design and review. (2) Every treatment plan receives a certified dental practitioner' approvals before aligners were manufactured. (3) The manufacturer is an ISO13485 certified facility which follows GMP standards during the manufacturing processes.
Non-Clinical performance Data
The DailyMate® Orthodontic Aligner System uses polyurethane as the raw material, same as the predicate device and reference device. The DailyMate® Orthodontic Aligner System is a device contacts mucosal membrane for a duration of greater than 30 days. The biocompatibility testing for the aligner materials was completed in accordance with ISO 10993 per the following:
- Part 5: Cytotoxicity Test .
- . Part 10: Sensitization Test
- Part 10: Oral Mucosa Irritation Test ●
The testing results demonstrate that the material of DailyMate® Orthodontic Aligner System is biocompatible for the intended use.
7
Image /page/7/Picture/0 description: The image shows the logo for Global Biotech. The logo consists of a green stylized "3D" on the left, followed by the words "GLOBAL" and "BIOTECH" stacked on top of each other in gray. The logo is simple and modern, and the use of green and gray gives it a clean and professional look.
The laboratory testing data was provided to confirm the quality of the DailyMate® Orthodontic Aligner System. A manufacturing validation report was also included to assure the substantial equivalence of the DailyMate® Orthodontic Aligner System.
Clinical performance Data
No clinical data was provided in this submission
Conclusion
The data included in this submission demonstrates that the DailyMate® Orthodontic Aligner System is substantially equivalent to the predicate device and the reference device in indications for use, mechanism of action, aligner design process, raw material and manufacturing fabrication process.