510(k) K231219
K231219 is an FDA 510(k) premarket notification submitted by Nobel Biocare Services AG for the device "NobelZygoma PureSet Tray". The FDA issued a decision of Substantially Equivalent on June 27, 2023. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Nobel Biocare Services AG has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2023
- Date Received
- April 28, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type