The following data is part of a premarket notification filed by Harvest Dental Products, Llc with the FDA for Harvest Dental Polymer Blocks.
| Device ID | K180578 |
| 510k Number | K180578 |
| Device Name: | Harvest Dental Polymer Blocks |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | Harvest Dental Products, LLC 905 Columbia Street Brea, CA 92821 |
| Contact | Sasha Der Avanessian |
| Correspondent | Sasha Der Avanessian Harvest Dental Products, LLC 905 Columbia Street Brea, CA 92821 |
| Product Code | EBG |
| Subsequent Product Code | EBI |
| Subsequent Product Code | MQC |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2018-12-12 |
| Summary: | summary |