510(k) K261456
K261456 is an FDA 510(k) premarket notification submitted by Dental Manufacturing S.p.A. for the device "Ruthinium Disc". The FDA issued a decision of Substantially Equivalent on August 5, 2026. The device falls under product code POW (Crown And Bridge, Long-Term Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Dental Manufacturing S.p.A. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 2026
- Date Received
- May 1, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Crown And Bridge, Long-Term Temporary, Resin
- Device Class
- Class II
- Regulation Number
- 872.3770
- Review Panel
- DE
- Submission Type
For the fabrication of long-term temporary crowns and bridges