Ruthinium Disc
FDA 510(k) clearance K261456 · decided 2026-08-05
Clearance details
- K-number
- K261456
- Device name
- Ruthinium Disc
- Applicant
- Dental Manufacturing S.p.A.
- Decision
- Substantially Equivalent
- Date received
- 2026-05-01
- Decision date
- 2026-08-05
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- POW
- Device class
- 2
- Regulation number
- 872.3770
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Badia Polesine, IT
- 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 |
|---|---|---|
| V-Print c&b temp (K231591) | Voco GmbH | 2023-07-31 |
Recalls involving this device
No recalls on record reference this clearance.