The following data is part of a premarket notification filed by The Straumann Co. with the FDA for Titanium Healing Caps.
| Device ID | K960634 |
| 510k Number | K960634 |
| Device Name: | TITANIUM HEALING CAPS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | THE STRAUMANN CO. ONE ALEWIFE CENTER Cambridge, MA 02140 -2317 |
| Contact | Carolyn Bitetti |
| Correspondent | Carolyn Bitetti THE STRAUMANN CO. ONE ALEWIFE CENTER Cambridge, MA 02140 -2317 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-14 |
| Decision Date | 1996-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031722393 | K960634 | 000 |
| 07630031722355 | K960634 | 000 |
| 07630031722331 | K960634 | 000 |
| 07630031722317 | K960634 | 000 |
| 07630031722294 | K960634 | 000 |
| 07630031722249 | K960634 | 000 |
| 07630031722225 | K960634 | 000 |