Arkligners
FDA 510(k) clearance K220835 · decided 2022-08-12
Clearance details
- K-number
- K220835
- Device name
- Arkligners
- Applicant
- Arklign Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2022-03-22
- Decision date
- 2022-08-12
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- NXC
- Device class
- 2
- Regulation number
- 872.5470
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
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| 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.