Clear Miracle is a clear orthodontic appliance designed to treat malocclusions in patients with permanent dentition (i.e., all second molars). It uses a series of gradual tooth movements to position teeth sequentially with continuous gentle force. Clear Miracle is intended for professional use only.

Device Description

Clear Miracle is a methacrylate-based resin designed for creating clear, light-cured aligners. It is supplied in 250-gram bottles made of high-density polyethylene (HDPE) and is a light yellow in color. Exposure to ultraviolet (UV) light within the 405–412-nanometer (nm) wavelength range causes the liquid resin to solidify into a three-dimensional structure. The resin contains a photoinitiator that begins the curing process at wavelengths between 405 and 412 nm. During additive manufacturing, Clear Miracle forms 50-μm-thick layers, achieving a resolution of 0.022 mm in the X and Y axes. This ensures the creation of high-precision orthodontic aligners through a layer-by-layer curing process.

AI/ML Overview

This document is a 510(k) Clearance Letter from the FDA for a medical device called "Clear Miracle," an orthodontic clear aligner. According to the document, clinical testing was not required for this device due to its substantial equivalence to a predicate device. Therefore, the provided text does not contain information about explicit acceptance criteria for device performance based on a study, a test set, expert involvement, or any human-in-the-loop (MRMC) or standalone algorithm performance studies.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (TERA HARZ CLEAR, K223355) through non-clinical testing and comparison of technological characteristics.

Here's a breakdown of the information that can be extracted or inferred, and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in the sense of predefined thresholds for a clinical study that the device must meet to prove its efficacy/safety in real-world scenarios. Instead, it reports performance values obtained from non-clinical mechanical property tests and compares them to the predicate device's values and relevant ISO standards. The implicit "acceptance criteria" here are that the 'Clear Miracle' device performs at least as well as the predicate device or meets the relevant ISO standard requirements.

Characteristic / Test	Acceptance Criteria (Implicit / From Standard)	Reported Device Performance (Clear Miracle)	Predicate Device (TERA HARZ CLEAR)	Difference
Ultimate Flexural Strength	≥50 MPa (ISO 20795-2:2013)	Min. 99 to Max. 105 MPa	Min. 62 to Max. 67 MPa	Superior
Flexural Modulus	≥1500 MPa (ISO 20795-2:2013)	Min. 1,629 to Max. 1924 MPa	Min. 1,545 to Max. 1,595 MPa	Superior
Residual Methyl Methacrylate Monomer	Implied: 0% (as per predicate)	0%	0%	No difference
Solubility	≤5 μg/mm³ (as per standard / predicate)	Min. 0 to Max. 1.0 μg/mm³	Min. 1.5 to Max. 2.1 μg/mm³	Superior (lower is better for solubility)
Water Sorption	≤32 μg/mm³ (as per standard / predicate)	Min. 14.0 to Max. 17.0 μg/mm³	Min. 13.0 to Max. 14.8 μg/mm³	Difference (slightly higher, but within standard)
Biocompatibility	Biocompatible according to ISO 10993-1	Biocompatible	Biocompatible	No difference
Appearance, Weight, Surface Characteristics, Color, Porosity	Smooth surface, high gloss, matched color, no porosity	Met expectations	Met expectations	No difference
Dimensional Accuracy (via Validation)	within ±0.150 mm	Within ±0.150 mm	N/A (Process validation for Clear Miracle)	N/A

2. Sample size used for the test set and the data provenance:

Test Set (for performance validation): The document does not specify a "test set" in the context of patient data or clinical cases. The "testing" referred to is laboratory-based non-clinical testing of materials and manufacturing processes. Therefore, information about patient sample sizes or their provenance (country, retrospective/prospective) is not applicable/provided.
The mechanical properties tests were conducted on "specimen plates" as per ISO 20795-2:2013. The exact number of specimens tested for each characteristic is not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/provided. As there was no clinical study testing the device's performance against human ground truth (e.g., diagnostic accuracy), there were no experts establishing ground truth in that sense. The "ground truth" for the non-clinical tests is based on the methods and measurements defined by the ISO standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/provided. No adjudication method was mentioned as there was no clinical reading or expert review process involved.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The device "Clear Miracle" is described as a "clear orthodontic appliance" made of resin, a physical device, and not an AI/software. Therefore, no MRMC study or AI assistance evaluation would be relevant or conducted for this type of product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. See point 5. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical mechanical property tests, the "ground truth" is established by the measurement standards and methodologies prescribed by ISO 20795-2:2013. This involves precise laboratory measurements of physical properties.

8. The sample size for the training set:

Not applicable/provided. There is no "training set" in the context of machine learning for this physical device. The manufacturing process does involve "optimization" and "validation" of print parameters, but this is not a machine learning training process.

9. How the ground truth for the training set was established:

Not applicable/provided. As there's no training set for an AI model, this question is not relevant.

In summary:

This FDA clearance for "Clear Miracle" is for a physical medical device (orthodontic aligner resin), not an AI/software product. The substantial equivalence determination was primarily based on non-clinical laboratory testing against well-established international standards (ISO 20795-2:2013, ISO 10993-1) and direct comparison of its material properties and manufacturing process with a previously cleared predicate device. Therefore, many of the questions related to clinical trials, AI performance, expert review, and ground truth establishment in a diagnostic context are not relevant to this specific device clearance.

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 22, 2025

ODS Co., Ltd.
℅ Kyung-Hwan Kim
Representative Consultant, RA/QA
SMB Korea Co.
7, Boramae-ro 5ga-gil, Dongjak-gu
606-ho, 607-ho
Seoul, 07071
SOUTH KOREA

Re: K251616
Trade/Device Name: Clear Miracle
Regulation Number: 21 CFR 872.5470
Regulation Name: Orthodontic Plastic Bracket
Regulatory Class: Class II
Product Code: NXC
Dated: May 21, 2025
Received: May 27, 2025

Dear Kyung-Hwan Kim:

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 (the 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 available 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.

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K251616 - Kyung-Hwan Kim Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251616 - Kyung-Hwan Kim Page 3

assistance/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., RAC, CQIA
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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FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known): K251616

Device Name: Clear Miracle

Indications for Use (Describe)

To fabricate an aligner with Clear Miracle, an Additive Manufacturing System (AMS) compatible with the following is required:

Brand	Type
Design:
Intraoral scanner	3Shape Trios 3
Design software	3Shape 3Shape Ortho System
Additive Manufacturing System:
3D Printer	Phrozen Sonic Mini 8K
Post-Curing:
Post-cure unit	Cubicon ODS Cure Box V3

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:

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"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."

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510(k) Summary For Clear Miracle

Prepared in Accordance with 21 CFR 807.92

K251616

I. Submitter Information

ODS Co., Ltd.
D-1204, 30 Songdomirae-ro, Yeonsu-gu, Incheon, Republic of Korea
Office Phone: +82-32-425-2804
Email: backkyungran@odsresin.com
Contact Person: Ms. Kyung-Ran Back, RA

Correspondent
SMB Korea Co.
#606~607, 7, Boramae-ro 5ga-gil, Dongjak-gu, Seoul, 07071, Republic of Korea
Contact Person: Kyung-hwan Kim, Representative Consultant, RA/QA
Phone: +82-10-2247-5579
Email: info@smbkorea.com

Date Prepared: May 30, 2025

II. Device Information

Trade or Proprietary Name: Clear Miracle
Common or Usual Name: Sequential Aligner
Classification Name: Orthodontic plastic bracket (21 CFR 872.5470)
Regulatory Class: Class II
Product Code: NXC
Classification Panel: Dental

III. Predicate Device

Device Name: TERA HARZ CLEAR (K223355)
Manufacturer: Graphy Inc.
Product Code: NXC
Classification: Class II (21 CFR 872.5470)

IV. Device Description

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(nm) wavelength range causes the liquid resin to solidify into a three-dimensional structure. The resin contains a photoinitiator that begins the curing process at wavelengths between 405 and 412 nm. During additive manufacturing, Clear Miracle forms 50-μm-thick layers, achieving a resolution of 0.022 mm in the X and Y axes. This ensures the creation of high-precision orthodontic aligners through a layer-by-layer curing process.

V. Indications for Use

To fabricate an aligner with Clear Miracle, an Additive Manufacturing System (AMS) compatible with the following is required:

Brand	Type
Design:
Intraoral scanner	3Shape Trios 3
Design software	3Shape 3Shape Ortho System
Additive Manufacturing System:
3D Printer	Phrozen Mini 8K
Post-Curing:
Post-cure unit	ODS Co., Ltd. ODS Cure Box V3

VI. Technological Characteristics Comparison

SUBJECT Device	PREDICATED Device (K223355)	Significant Difference
Manufacturer	ODS Co., Ltd.	Graphy Inc.
Trade Name	Clear Miracle	TERA HARZ CLEAR
Regulation Description	Orthodontic plastic bracket	Orthodontic plastic bracket
Regulation Number	21 CFR 872.5470	21 CFR 872.5470
Product Code	NXC	NXC
Class	II	II
Indications for Use	Clear Miracle is a clear orthodontic appliance designed to treat malocclusions in patients with permanent dentition (i.e., all second molars). It uses a series of gradual tooth movements to position teeth sequentially with continuous gentle force. Clear Miracle is intended for	TERA HARZ CLEAR is intended for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force. TERA HARZ CLEAR is intended

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SUBJECT Device	PREDICATED Device (K223355)	Significant Difference
	professional use only.	exclusively for professional dental work.
Mechanism of Action	Orthodontic tooth movement occurs when an appliance applies force to the teeth. Then, each tooth moves according to a predetermined plan based on the orthodontist's instructions.	Orthodontic tooth movement occurs through forces applied to the teeth by the appliance to the dentition as each tooth follows the programmed displacement based on a dental health professional's prescription.
In Use Duration	The aligners are worn for about one week, 20 to 22 hours per day, and then replaced with the next set. This process continues as prescribed by the orthodontist.	Aligners are worn for approximately 1 week 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 clinician.
Materials of Use	Methacrylate-based resins	Methacrylate-based resins
Manufacturing Technology	Additive	Additive
Performance Testing	ISO 20795-2:2013	ISO 20795-2:2013
Polishability	The specimen plates had present a smooth surface with a high gloss.	The specimen plates had present a smooth surface with a high gloss.
Color	The color matched.	The color matched.
Freedom from porosity	There was no porosity.	There was no porosity.
Ultimate Flexural Strength (≥50 MPa)	Min. 99 to Max. 105	Min. 62 to Max. 67
Flexural modulus (≥1500 MPa)	Min. 1,629 to Max. 1924	Min. 1,545 to Max. 1,595
Residual methyl methacrylate monomer	0%	0%
Solubility (≤5 μg/mm³)	Min. 0 to Max. 1.0	Min. 1.5 to Max. 2.1
Water sorption	Min. 14.0 to Max. 17.0	Min. 13.0 to Max. 14.8

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SUBJECT Device	PREDICATED Device (K223355)	Significant Difference
(≤32 μg/mm³)
Biocompatibility	Biocompatible according to ISO 10993-1	Biocompatible according to ISO 10993-1
OTC or Rx	Rx only	Rx only
Sterile	Not Applicable	Not Applicable
Shelf-life	2 years	2 years

VII. Performance Data

1. Non-Clinical Testing

The following performance data was provided in support of the substantial equivalence determination.

• Biocompatibility

Biocompatibility classification follows FDA Guidance and ISO 10993-1 standards. Devices are classified as surface-contacting with long-term mucosal membrane exposure (>30 days). They meet requirements outlined in ISO 7405:2018 for dental devices, ISO 10993-1:2018, and FDA guidance for biological evaluation. Testing includes cytotoxicity (ISO 10993-5), irritation (ISO 10993-10/23), and implantation (ISO 10993-6), confirming substantial equivalence to predicate device K223355.

• Mechanical Properties

Tests were conducted on the Clear Miracle in compliance with ISO 20795-2:2013, Dentistry – Base Polymers – Part 2: Orthodontic Base Polymers, to confirm substantial equivalence in safety and efficacy compared to the predicate device. These tests included evaluations of appearance, weight, surface characteristics, color, porosity, residual methyl methacrylate monomer content, ultimate flexural strength, flexural modulus, water sorption, and water solubility.

• Additive Manufacturing Process Validation

ODS Co., Ltd. completed validation of Clear Miracle photocurable resin for 3D-printed orthodontic aligners, meeting ISO 20795-2 standards and FDA guidelines. Tests evaluated post-cure optimization, print parameters, dimensional accuracy, and resin reusability. Measurements showed dimensional accuracy within ±0.150 mm and mechanical properties exceeding requirements (50 MPa flexural strength, 1,500 MPa modulus). Optimal parameters include 0° exit angle and centered positioning. Clear Miracle resin remained effective through seven consecutive print cycles, confirming process reliability.

2. Clinical Testing

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Clinical performance data were not required due to substantial equivalence to the predicate device.

VIII. Substantial Equivalence Conclusion

The Clear Miracle demonstrates substantial equivalence to the predicate device TERA HARZ CLEAR (K223355) through identical material composition, manufacturing processes, and intended use; superior flexural strength while meeting ISO 20795-2 and biocompatibility standards; and the absence of any new risks identified compared to the predicate.

Regulation Number and Section

§ 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.