The following data is part of a premarket notification filed by Bicon, Inc. with the FDA for Bicon Dental Implants Ii Part Abutment System.
Device ID | K972029 |
510k Number | K972029 |
Device Name: | BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | BICON, INC. 1153 CENTRE ST., SUITE 21 Boston, MA 02130 |
Contact | Vincent Morgan |
Correspondent | Vincent Morgan BICON, INC. 1153 CENTRE ST., SUITE 21 Boston, MA 02130 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-02 |
Decision Date | 1997-08-18 |