The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Thermoform Sheet Materials And Accessories.
| Device ID | K072522 |
| 510k Number | K072522 |
| Device Name: | THERMOFORM SHEET MATERIALS AND ACCESSORIES |
| Classification | Mouthguard, Prescription |
| Applicant | DENTSPLY INTERNATIONAL, INC. 221 W. PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL, INC. 221 W. PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-07 |
| Decision Date | 2007-11-16 |
| Summary: | summary |