510(k) K201563
K201563 is an FDA 510(k) premarket notification submitted by Quest Dental USA Corp. for the device "PuRE PMMA Disc". The FDA issued a decision of Substantially Equivalent on April 9, 2021. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Quest Dental USA Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2021
- Date Received
- June 10, 2020
- Clearance Type
- Special
- 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