510(k) K190930
K190930 is an FDA 510(k) premarket notification submitted by Parkell, Inc. for the device "SmarTemp X1". The FDA issued a decision of Substantially Equivalent on September 5, 2019. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Parkell, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2019
- Date Received
- April 10, 2019
- 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