The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Modification To Iti Dental Implant System.
| Device ID | K033922 |
| 510k Number | K033922 |
| Device Name: | MODIFICATION TO ITI DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INSTITUT STRAUMANN AG RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02451 |
| Contact | Carolyn Bitetti |
| Correspondent | Carolyn Bitetti INSTITUT STRAUMANN AG RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02451 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-18 |
| Decision Date | 2004-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031700919 | K033922 | 000 |
| 07630031718310 | K033922 | 000 |
| 07630031718372 | K033922 | 000 |
| 07630031718822 | K033922 | 000 |
| 07630031718877 | K033922 | 000 |
| 07630031719133 | K033922 | 000 |
| 07630031719171 | K033922 | 000 |
| 07630031719188 | K033922 | 000 |
| 07630031719195 | K033922 | 000 |
| 07630031701022 | K033922 | 000 |
| 07630031701015 | K033922 | 000 |
| 07630031701008 | K033922 | 000 |
| 07630031700926 | K033922 | 000 |
| 07630031700933 | K033922 | 000 |
| 07630031700940 | K033922 | 000 |
| 07630031700957 | K033922 | 000 |
| 07630031700964 | K033922 | 000 |
| 07630031700971 | K033922 | 000 |
| 07630031700988 | K033922 | 000 |
| 07630031700995 | K033922 | 000 |
| 07630031719201 | K033922 | 000 |
| 07630031719454 | K033922 | 000 |
| 07630031719744 | K033922 | 000 |
| 07630031719751 | K033922 | 000 |
| 07630031719768 | K033922 | 000 |
| 07630031719775 | K033922 | 000 |
| 07630031719782 | K033922 | 000 |
| 07630031719829 | K033922 | 000 |
| 07630031719836 | K033922 | 000 |
| 07630031719843 | K033922 | 000 |
| 07630031719737 | K033922 | 000 |
| 07630031719683 | K033922 | 000 |
| 07630031719638 | K033922 | 000 |
| 07630031719461 | K033922 | 000 |
| 07630031719478 | K033922 | 000 |
| 07630031719485 | K033922 | 000 |
| 07630031719539 | K033922 | 000 |
| 07630031719591 | K033922 | 000 |
| 07630031719607 | K033922 | 000 |
| 07630031719614 | K033922 | 000 |
| 07630031719621 | K033922 | 000 |
| 07630031719850 | K033922 | 000 |