Smilers Aligner
510(k) K212961
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212961 | Date20 Sep 2021 | StatusActive |
Official records
- FDA 510(k) database K212961
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Smilers
- 510(k) Number
- FDA product code
- NXC
- FDA applicant
- Biotech Dental Smilers, Sas
- Device class
- Class II
- Regulation
- 21 CFR Part 872.5470
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Smilers Aligner is a custom-made, Class IIa medical device designed for sequential dental alignment. It consists of transparent thermoplastic aligners used to gradually reposition teeth into desired positions, addressing orthodontic concerns through a series of incremental adjustments.
These aligners are supplied as single-use, sterile devices tailored to individual patient needs. They are intended for use in dental offices and require proper storage under controlled conditions to maintain sterility. The device is regulated under FDA 510K clearance (K212961) and complies with regulation number 872.5470, with no specific MRI safety restrictions noted.
Devices cleared under K212961
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Smilers Aligner | ALIGNEURS / Aligner | 03770020010002 | — | On the market |
| Smilers Aligner | ALIGNEURS / Aligner | 03770020010019 | — | On the market |
| Smilers Attachement placement aligner | GOUTP / Attachement placement aligner | 03770020010033 | — | On the market |
| Smilers Attachement placement aligner | GOUTP / Attachement placement aligner | 03770020010026 | — | On the market |
| Smilers Passive Appliance | GOUTPA / Passive Appliance | 03770020010040 | — | On the market |
| Smilers Reproduction Aligner | ALIGN_REPRO / Reproduction Aligner | 03770020010071 | — | On the market |
| Smilers Reproduction Aligner | ALIGN_REPRO / Reproduction Aligner | 03770020010088 | — | On the market |
| Smilers Retainer Appliance | GOUTC / Retainer Appliance | 03770020010057 | — | On the market |
| Smilers Retainer Appliance | GOUTC / Retainer Appliance | 03770020010064 | — | On the market |
Similar devices
Other devices filed under FDA product code NXC (Aligner, Sequential).
- LuxCreo Clear Aligner System by LuxCreo, Inc.
- Park Dental Research Aligners by Park Dental Research Corp
- Alien Aligners by ALIEN MILLING TECHNOLOGIES
- SmileSeries by Ordont Orthodontic Laboratories, Inc.
- Invisalign Pre-Formed Attachment System by Align Technology Inc.
- QuickAligners by Oral Image, Inc.
- Clear Aligner by Wuxi EA Medical Instruments Technologies Limited.
- Magic Clear Aligners by Voodoo Manufacturing, Inc.
- Custom-made Invisible Aligners by Zhejiang Yinchili Medical Technology Co., Ltd.
- Pearl Clear Aligner by Pearl Digital, Inc.