510(k) K180578
K180578 is an FDA 510(k) premarket notification submitted by Harvest Dental Products, LLC for the device "Harvest Dental Polymer Blocks". The FDA issued a decision of Substantially Equivalent on Dec 12, 2018. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Harvest Dental Products, LLC has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 12, 2018
- Date Received
- Mar 5, 2018
- 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
- 510(k)