Pre-Milled Blank
FDA 510(k) clearance K193425 · decided 2020-03-09
Clearance details
- K-number
- K193425
- Device name
- Pre-Milled Blank
- Applicant
- Arum Dentistry Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-10
- Decision date
- 2020-03-09
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Yuseong-Gu, Daejeon, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.