The following data is part of a premarket notification filed by Park Dental Research Corp. with the FDA for Startanius Dental Implant System.
| Device ID | K854749 |
| 510k Number | K854749 |
| Device Name: | STARTANIUS DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | PARK DENTAL RESEARCH CORP. 19 WEST 34TH STREET, SUITE 301 New York, NY 10001 |
| Contact | Wimmer |
| Correspondent | Wimmer PARK DENTAL RESEARCH CORP. 19 WEST 34TH STREET, SUITE 301 New York, NY 10001 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-26 |
| Decision Date | 1986-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D769STAR1180 | K854749 | 000 |
| D769IMSTAR11100 | K854749 | 000 |
| D769IMSTAR1110U0 | K854749 | 000 |
| D769IMSTAR11120 | K854749 | 000 |
| D769IMSTAR1112U0 | K854749 | 000 |
| D769IMSTAR11140 | K854749 | 000 |
| D769IMSTAR1114U0 | K854749 | 000 |
| D769IMSTAR1180 | K854749 | 000 |
| D769STAR1108U0 | K854749 | 000 |
| D769STAR11100 | K854749 | 000 |
| D769STAR1110U0 | K854749 | 000 |
| D769STAR11120 | K854749 | 000 |
| D769STAR1112U0 | K854749 | 000 |
| D769STAR11140 | K854749 | 000 |
| D769STAR1114U0 | K854749 | 000 |
| D769IMSTAR1108U0 | K854749 | 000 |