The following data is part of a premarket notification filed by Bio-lok Intl., Inc. with the FDA for Silhouette(tm) Ic Or Silhouette(tm) & Laser-lok (tm).
| Device ID | K032454 |
| 510k Number | K032454 |
| Device Name: | SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM) |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIO-LOK INTL., INC. P.O. BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan BIO-LOK INTL., INC. P.O. BOX 560 Stillwater, MN 55082 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-11 |
| Decision Date | 2004-03-04 |
| Summary: | summary |