The following data is part of a premarket notification filed by Planmeca Usa, Inc. with the FDA for Planmeca Sovereign.
| Device ID | K081699 |
| 510k Number | K081699 |
| Device Name: | PLANMECA SOVEREIGN |
| Classification | Unit, Operative Dental |
| Applicant | PLANMECA USA, INC. 100 N. GARY AVE. SUITE A Roselle, IL 60172 |
| Contact | Bob Pienkowski |
| Correspondent | Bob Pienkowski PLANMECA USA, INC. 100 N. GARY AVE. SUITE A Roselle, IL 60172 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-17 |
| Decision Date | 2008-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035420100 | K081699 | 000 |