Dental · 98 clearances · 74 unique sponsors
| Sponsor | Clearances | Last 12 mo | Most recent |
|---|---|---|---|
| Align Technology, Inc. | 8 | 3 | 2025-10-23 |
| Smylio, Inc. | 3 | 1 | 2026-05-08 |
| 3M Company, Unitek Orthodontic Products | 3 | 0 | 2023-09-29 |
| Ormco Corporation | 3 | 0 | 2025-02-20 |
| Graphy, Inc. | 2 | 0 | 2024-03-05 |
| Dentsply Sirona, Inc. | 2 | 1 | 2026-04-15 |
| Wuxi EA Medical Instruments Technologies Limited. | 2 | 0 | 2023-06-13 |
| Ulab Systems, Inc. | 2 | 0 | 2022-02-24 |
| New England Ortho Lab, Inc. | 2 | 0 | 2021-01-06 |
| Clearcorrect, LLC | 2 | 0 | 2022-10-05 |
| LuxCreo, Inc. | 2 | 0 | 2025-04-08 |
| Blue Sky Bio, LLC | 2 | 0 | 2024-04-03 |
| Dror Orthodesign | 2 | 1 | 2026-02-03 |
| Zhejiang Yinchili Medical Technology Co., Ltd. | 2 | 0 | 2023-04-17 |
| Tns Co., Ltd. | 2 | 1 | 2025-09-11 |
| Brius Technologies, Inc. | 1 | 0 | 2021-01-22 |
| Cdb Corporation | 1 | 0 | 2021-06-04 |
| Geniova Technologies Sociedad Limitada | 1 | 0 | 2024-12-12 |
| Xplora 3D Europe S.L | 1 | 0 | 2024-12-20 |
| Park Dental Research Corporation | 1 | 0 | 2024-04-05 |
| Laxmi Dental Exports Pvt, Ltd. | 1 | 0 | 2021-04-26 |
| Arklign Laboratories | 1 | 0 | 2022-08-12 |
| Clear Moves Aligners | 1 | 0 | 2024-08-01 |
| Drake Precision Dental Laboratory, Inc. | 1 | 0 | 2020-11-09 |
| Aso International Manila, Inc. | 1 | 0 | 2021-02-26 |
Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
|---|---|---|---|---|
| D8010 | CPT | — | High | ADA CDT code for limited orthodontic treatment of the adolescent dentition using clear aligner and/or functional appliances |
| D8080 | CPT | — | Medium | ADA CDT code for comprehensive orthodontic treatment of adolescent dentition; clear aligner technique |
| Date | K-number | Sponsor | Device |
|---|---|---|---|
| 2026-07-02 | K260527 | Avinent Implant System S.L.U. | FACE4D Aligner |
| 2026-05-08 | K260788 | Smylio, Inc. | Smylio Aligners |
| 2026-04-15 | K260722 | Dentsply Sirona, Inc. | SureSmile Aligner (ASSY500020) |
| 2026-02-03 | K253282 | Dror Orthodesign , Ltd. | ZSmile System |
| 2026-01-07 | K251454 | Beame Medical Technology (Shenzhen) Limited | Clear Aligner (SCF-3348) |
| 2025-11-07 | K250739 | Dreve Dentamid GmbH | Primeprint Direct Aligner |
| 2025-10-23 | K252931 | Align Technology, Inc. | Invisalign® Palatal Expander System |
| 2025-10-09 | K252870 | Align Technology, Inc. | Invisalign Specifix Attachment System |
| 2025-09-11 | K251758 | Tns Co., Ltd. | Serafin® |
| 2025-08-29 | K252380 | Align Technology, Inc. | Invisalign System |
| 2025-08-27 | K251415 | Aidite (Qinhuangdao) Technology Co., Ltd. | Additively Manufactured Aligner Resin |
| 2025-07-22 | K251616 | Ods Co., Ltd. | Clear Miracle |
| 2025-05-21 | K242637 | Mem Dental Technology Co., Ltd. | MEM Clear Aligner System |
| 2025-04-08 | K250343 | LuxCreo, Inc. | LuxCreo Clear Aligner System |
| 2025-02-20 | K250487 | Ormco Corporation | SparkTM Clear Aligner System |
| 2025-01-16 | K242715 | Pearl Digital, Inc. | Pearl Clear Aligner |
| 2024-12-20 | K242929 | Xplora 3D Europe S.L | Fas Aligner System |
| 2024-12-19 | K242892 | Cristaline Aligners GmbH | Cristaline Aligners Z FLX |
| 2024-12-12 | K233152 | Geniova Technologies Sociedad Limitada | GENIOVA aligners |
| 2024-10-11 | K240501 | Ormco Corporation | Spark Clear Aligner System |
| 2024-08-08 | K233356 | Laxmi Dental Export Pvt., Ltd. | Illusion Aligner Pro: Illusion Aligner FLX |
| 2024-08-01 | K241137 | Clear Moves Aligners | Clear Moves Aligner |
| 2024-07-26 | K241187 | Alien Milling Technologies | Alien Aligners |
| 2024-06-18 | K241412 | Align Technology, Inc. | Invisalign System |
| 2024-04-05 | K233935 | Park Dental Research Corporation | DigiLine Direct Print Aligner System |