The following data is part of a premarket notification filed by Sulzer Calcitek, Inc. with the FDA for Temporary Gingival Cuff And Impression Post And Implant Analog.
| Device ID | K001786 |
| 510k Number | K001786 |
| Device Name: | TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SULZER CALCITEK, INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Foster Boop |
| Correspondent | Foster Boop SULZER CALCITEK, INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-13 |
| Decision Date | 2000-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024012981 | K001786 | 000 |
| 00889024012646 | K001786 | 000 |
| 00889024012639 | K001786 | 000 |
| 00889024012622 | K001786 | 000 |
| 00889024012615 | K001786 | 000 |
| 00889024012608 | K001786 | 000 |
| 00889024012592 | K001786 | 000 |
| 00889024012585 | K001786 | 000 |
| 00889024012578 | K001786 | 000 |
| 00889024012653 | K001786 | 000 |
| 00889024012660 | K001786 | 000 |
| 00889024012677 | K001786 | 000 |
| 00889024012974 | K001786 | 000 |
| 00889024012950 | K001786 | 000 |
| 00889024012943 | K001786 | 000 |
| 00889024012929 | K001786 | 000 |
| 00889024012912 | K001786 | 000 |
| 00889024012707 | K001786 | 000 |
| 00889024012691 | K001786 | 000 |
| 00889024012684 | K001786 | 000 |
| 00889024012561 | K001786 | 000 |