The following data is part of a premarket notification filed by The Straumann Co. with the FDA for Plastic Protection Healing Caps.
| Device ID | K962023 |
| 510k Number | K962023 |
| Device Name: | PLASTIC PROTECTION HEALING CAPS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | THE STRAUMANN CO. ONE ALEWIFE CENTER Cambridge, MA 02140 -2317 |
| Contact | Amy M Garnder |
| Correspondent | Amy M Garnder 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 | 1996-05-23 |
| Decision Date | 1996-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031722461 | K962023 | 000 |
| 07630031722454 | K962023 | 000 |
| 07630031722447 | K962023 | 000 |
| 07630031722430 | K962023 | 000 |
| 07630031722423 | K962023 | 000 |
| 07630031722416 | K962023 | 000 |
| 07630031722218 | K962023 | 000 |