Beame Medical Technology (Shenzhen) Limited · Class II · Cleared Jan 7, 2026
| K-number | K251454 |
| Device name | Clear Aligner (SCF-3348) |
| Applicant | Beame Medical Technology (Shenzhen) Limited |
| Product code | NXC |
| Device class | Class II |
| Decision date | Jan 7, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 872.5470 |
The Clear Aligner (SCF-3348) is a custom-made orthodontic device indicated for aligning permanent teeth through treatment of misalignment and malocclusion. It uses thermoplastic polyurethane material formed via thermoforming over 3D-printed molds based on digitally planned sequential tooth positions.
The device uses thermoplastic polyurethane (TPU) material and thermoforming manufacturing methods identical to predicate devices. It employs CAD/CAM software (3Shape Ortho System) to create treatment plans and 3D printer files that guide mold fabrication, with no colorants, dyes, or additives introduced during processing.
ISO 10993-1:2018, ISO 7405:2018, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021, ISO 10993-3:2014, and ISO 10993-11:2017 covering biocompatibility, cytotoxicity, skin sensitization, irritation, genotoxicity, and systemic toxicity.
The Clear Aligner is substantially equivalent because it shares identical indications for use, materials (TPU), mode of action (continuous gentle force), and manufacturing method (thermoforming) with predicate device K233356. Raw materials are sourced from reference device K230237, and manufacturing only changes physical shape without affecting chemical properties, supporting reliance on predicate biocompatibility test data.
View the full FDA submission: accessdata.fda.gov