The following data is part of a premarket notification filed by Inovativ, Llc with the FDA for Poly-carb.
| Device ID | K022030 |
| 510k Number | K022030 |
| Device Name: | POLY-CARB |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | INOVATIV, LLC 1155 TWIN HILLS DR. Jefferson, OR 97352 |
| Contact | Robert Bowers |
| Correspondent | Robert Bowers INOVATIV, LLC 1155 TWIN HILLS DR. Jefferson, OR 97352 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-21 |
| Decision Date | 2002-08-28 |
| Summary: | summary |