# K251616: Clear Miracle

- Pathway: 510(k) (Traditional)
- Applicant: Ods Co., Ltd.
- Decided: Jul 22, 2025 after 56 days
- Product code: NXC (Aligner, Sequential)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K780619 (1978). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223355: Tera Harz Clear, Graphy, Inc. (2022) Summary page 5.

## 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 professional use only. 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

Source page: https://510kreport.com/device/K251616
Methodology: https://510kreport.com/methodology