510(k) clearance
OrthoFit Aligner (OrthoFit Aligner A2)
- 510(k) number
- K262433
- Applicant
- Spident Co., Ltd.
- Decision date
- Oct 13, 2026
- Date received
- Jul 16, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- DYH
- Device type
- Adhesive, Bracket And Tooth Conditioner, Resin
- Device class
- Class II
- Regulation
- 21 CFR 872.3750
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Incheon, KR