The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Disposa-shield(tm) Infection Control Barrier.
| Device ID | K900093 |
| 510k Number | K900093 |
| Device Name: | DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Contact | Jeffery Lehn |
| Correspondent | Jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-08 |
| Decision Date | 1990-04-06 |