The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Cares Bridge; Straumann Cares Dolder Bar.
| Device ID | K101465 |
| 510k Number | K101465 |
| Device Name: | STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Janet Kay |
| Correspondent | Janet Kay INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-26 |
| Decision Date | 2010-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031701831 | K101465 | 000 |
| 07630031701954 | K101465 | 000 |
| 07630031701961 | K101465 | 000 |
| 07630031701978 | K101465 | 000 |
| 07630031701985 | K101465 | 000 |
| 07630031701992 | K101465 | 000 |
| 07630031702005 | K101465 | 000 |
| 07630031702012 | K101465 | 000 |
| 07630031702029 | K101465 | 000 |
| 07630031701947 | K101465 | 000 |
| 07630031701930 | K101465 | 000 |
| 07630031701923 | K101465 | 000 |
| 07630031701848 | K101465 | 000 |
| 07630031701855 | K101465 | 000 |
| 07630031701862 | K101465 | 000 |
| 07630031701879 | K101465 | 000 |
| 07630031701886 | K101465 | 000 |
| 07630031701893 | K101465 | 000 |
| 07630031701909 | K101465 | 000 |
| 07630031701916 | K101465 | 000 |
| 07630031702036 | K101465 | 000 |
| 07630031702043 | K101465 | 000 |
| 07630031702524 | K101465 | 000 |
| 07630031702531 | K101465 | 000 |
| 07630031702548 | K101465 | 000 |
| 07630031702555 | K101465 | 000 |
| 07630031702562 | K101465 | 000 |
| 07630031702579 | K101465 | 000 |
| 07630031702586 | K101465 | 000 |
| 07630031702593 | K101465 | 000 |
| 07630031702425 | K101465 | 000 |
| 07630031702418 | K101465 | 000 |
| 07630031702401 | K101465 | 000 |
| 07630031702050 | K101465 | 000 |
| 07630031702067 | K101465 | 000 |
| 07630031702340 | K101465 | 000 |
| 07630031702357 | K101465 | 000 |
| 07630031702364 | K101465 | 000 |
| 07630031702371 | K101465 | 000 |
| 07630031702388 | K101465 | 000 |
| 07630031702395 | K101465 | 000 |
| 07630031702609 | K101465 | 000 |