The following data is part of a premarket notification filed by Dentsply Intl., Inc. with the FDA for Qmix 2in1 Endodontic Irrigating Solution.
| Device ID | K103244 |
| 510k Number | K103244 |
| Device Name: | QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION |
| Classification | Cleanser, Root Canal |
| 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 | KJJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-02 |
| Decision Date | 2011-02-14 |
| Summary: | summary |