The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Alpha-dent Root Canal Sealer & Filler.
| Device ID | K963922 |
| 510k Number | K963922 |
| Device Name: | ALPHA-DENT ROOT CANAL SEALER & FILLER |
| Classification | Resin, Root Canal Filling |
| Applicant | WALLACE A. ERICKSON & CO. 1920 NORTH CLYBOURN AVE. Chicago, IL 60614 |
| Contact | Abner T De La Cruz |
| Correspondent | Abner T De La Cruz WALLACE A. ERICKSON & CO. 1920 NORTH CLYBOURN AVE. Chicago, IL 60614 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-30 |
| Decision Date | 1996-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818207020208 | K963922 | 000 |
| 20818207020202 | K963922 | 000 |
| 00850002458657 | K963922 | 000 |
| 10850002458616 | K963922 | 000 |