The following data is part of a premarket notification filed by Steiner Laboratories with the FDA for Oral Bond.
| Device ID | K142130 |
| 510k Number | K142130 |
| Device Name: | ORAL BOND |
| Classification | Cement, Dental |
| Applicant | STEINER LABORATORIES 1051 Olsen Street, Building 3611 Henderson, NV 89011 |
| Contact | Gregory G Steiner |
| Correspondent | Gregory G Steiner STEINER LABORATORIES 1051 Olsen Street, Building 3611 Henderson, NV 89011 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-04 |
| Decision Date | 2016-06-06 |
| Summary: | summary |