The following data is part of a premarket notification filed by Oco Biomedical with the FDA for Universal Maxillary Molar.
| Device ID | K110337 |
| 510k Number | K110337 |
| Device Name: | UNIVERSAL MAXILLARY MOLAR |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OCO BIOMEDICAL 8500 WASHINGTON ST. NE SUITE A-1 Albuquerque, NM 87113 |
| Contact | Jack Bloom |
| Correspondent | Jack Bloom OCO BIOMEDICAL 8500 WASHINGTON ST. NE SUITE A-1 Albuquerque, NM 87113 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-04 |
| Decision Date | 2012-03-16 |
| Summary: | summary |