The following data is part of a premarket notification filed by Columbus Dental Mfg. Co. with the FDA for Ortho-bite Wax Wafer.
| Device ID | K863758 |
| 510k Number | K863758 |
| Device Name: | ORTHO-BITE WAX WAFER |
| Classification | Wax, Dental, Intraoral |
| Applicant | COLUMBUS DENTAL MFG. CO. 1000 CHOUTEAU AVE. P.O. BOX 620 St. Louis, MO 63188 |
| Contact | John S Frierdich |
| Correspondent | John S Frierdich COLUMBUS DENTAL MFG. CO. 1000 CHOUTEAU AVE. P.O. BOX 620 St. Louis, MO 63188 |
| Product Code | EGD |
| CFR Regulation Number | 872.6890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-25 |
| Decision Date | 1986-10-07 |