The following data is part of a premarket notification filed by Ipco Corp. with the FDA for Endex Broach, Endodontic.
| Device ID | K800292 | 
| 510k Number | K800292 | 
| Device Name: | ENDEX BROACH, ENDODONTIC | 
| Classification | Broach, Endodontic | 
| Applicant | IPCO CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | EKW | 
| CFR Regulation Number | 872.4565 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1980-02-11 | 
| Decision Date | 1980-02-19 |