DailyMate Orthodontic Aligner System

K212803 · 3D Global Biotech, Inc. · NXC · May 23, 2022 · Dental

Device Facts

• Record ID: K212803
• Device Name: DailyMate Orthodontic Aligner System
• Applicant: 3D Global Biotech, Inc.
• Product Code: NXC · Dental
• Decision Date: May 23, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

DailyMate Orthodontic Aligner System consists of custom-made, clear, removable plastic aligners; fabricated from medical-grade polyurethane. Input: dental impressions or digital scans. Processing: 3Shape Ortho System software used by dental professionals to design treatment plans and generate 3D-printed molds; aligners fabricated via thermoforming. Output: series of sequential aligners. Usage: clinic setting; operated by dental practitioners. Mechanism: aligners worn by patient as prescribed; exert continuous gentle force to achieve progressive tooth realignment. Benefit: correction of malocclusion. Healthcare provider reviews and approves treatment plans before manufacturing.

Clinical Evidence

No clinical data provided. Bench testing performed comparing DailyMate to Invisalign, including pH change, water absorption, and tensile strength tests. Biocompatibility testing conducted per ISO 10993 (cytotoxicity, sensitization, oral mucosa irritation).

Technological Characteristics

Material: medical-grade polyurethane. Principle: sequential thermoformed plastic aligners applying continuous force. Connectivity: uses 3Shape Ortho System software for design. Sterilization: none. Form factor: custom-fitted dental trays.

Indications for Use

Indicated for treatment of tooth malocclusion in patients with permanent dentition.

Regulatory Classification

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.

Predicate Devices

• SureCure Orthodontic Aligner System (K182329)

Reference Devices

• Invisalign System (K143630)
• 3Shape Ortho System (K152086)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

| <div> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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: [phone]

# 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<br>Aligner System | K182329 | Digital Orthodontic<br>Care |
|---------------------|----------------------------------------|---------|-----------------------------|
| Predicate | | | |
| Reference<br>Device | Invisalign System | K143630 | Align Technology, Inc. |
| Reference<br>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

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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<br>equivalence<br>Analysis |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Device name | DailyMate®<br>Orthodontic<br>Aligner System | SureCure<br>Orthodontic Aligner<br>System | Invisalign<br>System | |
| Manufacturer | 3D Global<br>Biotech Inc. | Digital Orthodontic<br>Care | Align<br>Technology, Inc. | |
| 510(K) No. | K212803 | K182329 | K143630 | - |
| Regulation<br>No. | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Classification<br>Name | Orthodontic<br>Plastic Bracket | Orthodontic Plastic<br>Bracket | Orthodontic<br>Plastic Bracket | Same |
| Regulatory<br>Class | Class II | Class II | Class II | Same |
| Product Code | NXC | NXC | NXC | Same |
| Indications<br>for<br>use/Intended<br>use | The DailyMate<br>Orthodontic<br>Aligner System is<br>indicated for the<br>treatment of tooth<br>malocclusion in<br>patients with<br>permanent<br>dentition. The<br>aligner system<br>repositions teeth<br>by way of<br>continuous gentle<br>force. | The SureCure<br>Orthodontic Aligner<br>System is indicated<br>for the treatment of<br>tooth malocclusion<br>in patients with<br>permanent dentition.<br>The aligner system<br>repositions teeth by<br>way of continuous<br>gentle force. | The Invisalign<br>System is indicated<br>for the alignment of<br>teeth during<br>orthodontic<br>treatment of<br>malocclusion | Same as the<br>predicate<br>device |
| Mechanism of<br>Action | Based on the<br>clinician's<br>treatment plan,<br>each aligner is<br>used for a<br>defined period of<br>time to exert | Based on the<br>clinician's treatment<br>plan, each aligner is<br>used for a defined<br>period of time to<br>exert gentle force to<br>achieve progressive | Sequential aligners<br>apply continuous<br>gentle force to the<br>teeth | Same |
| | gentle force to<br>achieve<br>progressive<br>realignment of<br>the teeth. This<br>occurs over time<br>until the final<br>correction has<br>been achieved. | realignment of the<br>teeth. This occurs<br>over time until the<br>final correction has<br>been achieved. | | |
| Method of<br>Use | Each preformed<br>plastic tray is<br>worn by the<br>patient as<br>prescribed by the<br>dental<br>practitioner,<br>usually a few<br>weeks prior to<br>using the next<br>sequential aligner<br>tray. | Each preformed<br>plastic tray is worn<br>by the patient as<br>prescribed by the<br>dental practitioner,<br>usually a few weeks<br>prior to using the<br>next sequential<br>aligner tray. | Aligners are worn for<br>approximately 2<br>weeks of 20-22<br>hours of wear per<br>day, after which it is<br>replaced by the next<br>stage aligners. This<br>is<br>repeated for duration<br>as prescribed by the<br>Dental<br>Practitioner | Same as the<br>predicate<br>device |
| Method of<br>Manufacture | Using software,<br>molds/models are<br>3D printed based<br>on the treatment<br>plan. Aligners<br>are fabricated on<br>the molds using a<br>thermoforming<br>machine. | Using software,<br>molds/models are<br>3D printed based on<br>the treatment plan.<br>Aligners are<br>fabricated on the<br>molds using a<br>thermoforming<br>machine. | The Align 3-D<br>Software uses a<br>scan of a PVS<br>impression<br>or a digital scan<br>(which represents<br>an untreated<br>state) to<br>generate the<br>image of a final,<br>treated state and<br>then interprets a<br>series of images<br>that represent<br>intermediate teeth<br>states. The dental<br>practitioner then<br>reviews these<br>images and has<br>the option to<br>reject or request<br>modifications to<br>the set-up prior to<br>approving it for<br>aligner<br>fabrication. Once<br>the dental<br>practitioner | Same as the<br>predicate<br>device |
| | | | approves the<br>treatment plan,<br>the software<br>converts the files<br>to produce the<br>series of custom-<br>made aligners | |
| Raw Material<br>Used | Thin<br>thermoformed<br>polyurethane | Thin thermoformed<br>polyurethane | Thin<br>thermoformed<br>polyurethane | Similar |
| OTC or Rx | Rx | Rx | Rx | Same |
| Software Use | 3Shape Ortho<br>System | 3Shape Ortho<br>System | Invisalign<br>System 3-D<br>software | Same as the<br>predicate<br>device |
| Sterilization | No | No | No | Same |

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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.

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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.

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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.