ClearPath Aligner
FDA 510(k) clearance K162609 · decided 2017-07-06
Clearance details
- K-number
- K162609
- Device name
- ClearPath Aligner
- Applicant
- Clearpath Orthodontics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-09-19
- Decision date
- 2017-07-06
- Days to decision
- 290 days
- Clearance type
- Traditional
- Product code
- NXC
- Device class
- 2
- Regulation number
- 872.5470
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Johar Town, PK
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Clearpath Orthodontics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FACE4D Aligner (K260527) | Avinent Implant System S.L.U. | 2026-07-02 |
| Smylio Aligners (K260788) | Smylio, Inc. | 2026-05-08 |
| SureSmile Aligner (ASSY500020) (K260722) | Dentsply Sirona, Inc. | 2026-04-15 |
| ZSmile System (K253282) | Dror Orthodesign , Ltd. | 2026-02-03 |
| Clear Aligner (SCF-3348) (K251454) | Beame Medical Technology (Shenzhen) Limited | 2026-01-07 |
| Primeprint Direct Aligner (K250739) | Dreve Dentamid GmbH | 2025-11-07 |
| Invisalign® Palatal Expander System (K252931) | Align Technology, Inc. | 2025-10-23 |
| Invisalign Specifix Attachment System (K252870) | Align Technology, Inc. | 2025-10-09 |
| Serafin® (K251758) | Tns Co., Ltd. | 2025-09-11 |
| Invisalign System (K252380) | Align Technology, Inc. | 2025-08-29 |
| Additively Manufactured Aligner Resin (K251415) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-08-27 |
| Clear Miracle (K251616) | Ods Co., Ltd. | 2025-07-22 |
Recalls involving this device
No recalls on record reference this clearance.