XERO-alpha
FDA 510(k) clearance K242591 · decided 2024-11-01
Clearance details
- K-number
- K242591
- Device name
- XERO-alpha
- Applicant
- DRTECH Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-08-30
- Decision date
- 2024-11-01
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- EHD
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Jungwon-Gu, Seongnam-Si, KR
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| Rextar Pro (K242185) | Raypia Co., Ltd. | 2024-12-04 |
| WERAY (K241963) | Picopack Co., Ltd. | 2024-07-30 |
| LifeRay Intraoral Handheld X-ray System (K241305) | Lucas Lifecare | 2024-07-05 |
| REMEX-GR100 (K240759) | Remedi Co., Ltd. | 2024-05-13 |
| XVbeam2000 (K233914) | Shenzhen Xpectvision Technology Co., Ltd. | 2024-02-08 |
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Recalls involving this device
No recalls on record reference this clearance.