The following data is part of a premarket notification filed by Estrad B.v. with the FDA for Perio Control Ii.
| Device ID | K972642 |
| 510k Number | K972642 |
| Device Name: | PERIO CONTROL II |
| Classification | Carver, Wax, Dental |
| Applicant | ESTRAD B.V. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm ESTRAD B.V. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | EIK |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-15 |
| Decision Date | 1998-01-26 |
| Summary: | summary |