The following data is part of a premarket notification filed by Dentsply Intl., Inc. with the FDA for Dentin Desensitizer Agent.
| Device ID | K073117 |
| 510k Number | K073117 |
| Device Name: | DENTIN DESENSITIZER AGENT |
| Classification | Varnish, Cavity |
| Applicant | DENTSPLY INTL., INC. SUSQUEHANNA COMMERCE CENTER 221 W PHILADELPHIA ST. STE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTL., INC. SUSQUEHANNA COMMERCE CENTER 221 W PHILADELPHIA ST. STE 60 York, PA 17404 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-05 |
| Decision Date | 2007-12-19 |
| Summary: | summary |