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 |