The following data is part of a premarket notification filed by Advanced Aeromedical, Inc. with the FDA for Bio-post Dental Post System.
| Device ID | K974649 |
| 510k Number | K974649 |
| Device Name: | BIO-POST DENTAL POST SYSTEM |
| Classification | Post, Root Canal |
| Applicant | ADVANCED AEROMEDICAL, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula ADVANCED AEROMEDICAL, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Product Code | ELR |
| CFR Regulation Number | 872.3810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-12 |
| Decision Date | 1998-05-01 |
| Summary: | summary |