510(k) K253461
K253461 is an FDA 510(k) premarket notification submitted by Meta Systems Co., Ltd. for the device "Demi Pro". The FDA issued a decision of Substantially Equivalent on October 14, 2025. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Meta Systems Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 14, 2025
- Date Received
- October 7, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Activator, Ultraviolet, For Polymerization
- Device Class
- Class II
- Regulation Number
- 872.6070
- Review Panel
- DE
- Submission Type