510(k) K240538
K240538 is an FDA 510(k) premarket notification submitted by Formlabs Ohio, Inc. for the device "Premium Teeth Resin". The FDA issued a decision of Substantially Equivalent on Jul 19, 2024. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Formlabs Ohio, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 19, 2024
- Date Received
- Feb 26, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Crown And Bridge, Temporary, Resin
- Device Class
- Class II
- Regulation Number
- 872.3770
- Review Panel
- DE
- Submission Type