Customized Abutment
FDA 510(k) clearance K223634 · decided 2023-04-28
Clearance details
- K-number
- K223634
- Device name
- Customized Abutment
- Applicant
- Arum Dentistry Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-12-05
- Decision date
- 2023-04-28
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Daejeon, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.