The following data is part of a premarket notification filed by Puricore, Inc. with the FDA for Aquatine Ec Endodontic Cleanser.
| Device ID | K061689 |
| 510k Number | K061689 |
| Device Name: | AQUATINE EC ENDODONTIC CLEANSER |
| Classification | Cleanser, Root Canal |
| Applicant | PURICORE, INC. 320 KING OF PRUSSIA ROAD SUITE 200 Radnor, PA 19087 |
| Contact | Howard Mann |
| Correspondent | Howard Mann PURICORE, INC. 320 KING OF PRUSSIA ROAD SUITE 200 Radnor, PA 19087 |
| 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 | 2006-06-15 |
| Decision Date | 2006-08-24 |
| Summary: | summary |