SmileInspector
FDA 510(k) clearance K252507 · decided 2026-01-07
Clearance details
- K-number
- K252507
- Device name
- SmileInspector
- Applicant
- Amv Consulting, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-08-08
- Decision date
- 2026-01-07
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- PNN
- Device class
- 2
- Regulation number
- 872.5470
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LingOral Dental Design System (K260419) | Hangzhou ChohoTech Co., Ltd. | 2026-05-08 |
| SureSmile Software (K253565) | Dentsply Sirona, Inc. | 2026-03-04 |
| Celebrace Software (K253343) | Celebrace | 2025-12-29 |
| Laon Ortho (K250198) | Laon Medi, Inc. | 2025-04-23 |
| Progressive Orthodontics App (K241153) | Progressive Aligners, Inc. | 2024-10-11 |
| RAYDENT SW (K233625) | Ray Co., Ltd. | 2024-05-16 |
| Align Studio (K232564) | Laon Medi, Inc. | 2024-03-12 |
| Clevaligner Software (V1.0.0) (K233616) | Clevaligner, Ltd. | 2024-01-11 |
| NemoCast (K232549) | Software Nemotec S.L. | 2023-11-21 |
| Titan Dental Design (K232429) | Clearadvance, LLC | 2023-10-13 |
| iOrtho (K223518) | Shanghai EA Medical Instruments Co., Ltd. | 2023-06-13 |
| HDH Treatment Planning System (K212173) | Cdb Corporation | 2022-01-25 |
Recalls involving this device
No recalls on record reference this clearance.