The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Citric Acid 20% Solution, Model 329.
| Device ID | K063703 |
| 510k Number | K063703 |
| Device Name: | CITRIC ACID 20% SOLUTION, MODEL 329 |
| Classification | Cleanser, Root Canal |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Corey Jaseph |
| Correspondent | Corey Jaseph ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | KJJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-13 |
| Decision Date | 2006-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205105523 | K063703 | 000 |