The following data is part of a premarket notification filed by Jordco, Inc. with the FDA for Rcng: Root Canal Negotiating Gel; Model Rcng.
| Device ID | K992484 |
| 510k Number | K992484 |
| Device Name: | RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG |
| Classification | Cleanser, Root Canal |
| Applicant | JORDCO, INC. 595 N.W. 167TH AVE. Beaverton, OR 97006 |
| Contact | Hal J Oien |
| Correspondent | Hal J Oien JORDCO, INC. 595 N.W. 167TH AVE. Beaverton, OR 97006 |
| 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 | 1999-07-26 |
| Decision Date | 1999-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859611006006 | K992484 | 000 |
| 00859611006716 | K992484 | 000 |