The following data is part of a premarket notification filed by Columbus Dental Mfg. Co. with the FDA for Pekalux(tm).
| Device ID | K872243 |
| 510k Number | K872243 |
| Device Name: | PEKALUX(TM) |
| Classification | Material, Tooth Shade, Resin |
| Applicant | COLUMBUS DENTAL MFG. CO. 1000 CHOUTEAU AVE. P.O. BOX 620 St. Louis, MO 63188 |
| Contact | Cheryl V Zimmerman |
| Correspondent | Cheryl V Zimmerman COLUMBUS DENTAL MFG. CO. 1000 CHOUTEAU AVE. P.O. BOX 620 St. Louis, MO 63188 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-11 |
| Decision Date | 1987-07-07 |