The following data is part of a premarket notification filed by Harvest Dental Products, Llc with the FDA for Harvest Dental Polymer Blocks (zcad, Aurora).
| Device ID | K132937 |
| 510k Number | K132937 |
| Device Name: | HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | HARVEST DENTAL PRODUCTS, LLC 4281 EXPRESS LANE STE # L4094 Sarasota, FL 34238 |
| Contact | Andrew Rowe |
| Correspondent | Andrew Rowe HARVEST DENTAL PRODUCTS, LLC 4281 EXPRESS LANE STE # L4094 Sarasota, FL 34238 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-18 |
| Decision Date | 2014-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D040724661 | K132937 | 000 |
| D040725021 | K132937 | 000 |
| D040724781 | K132937 | 000 |
| D040724721 | K132937 | 000 |
| D040724601 | K132937 | 000 |