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 |