The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Summa Disk.
| Device ID | K833038 |
| 510k Number | K833038 |
| Device Name: | SUMMA DISK |
| Classification | Instrument, Diamond, Dental |
| Applicant | SHOFU DENTAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DZP |
| CFR Regulation Number | 872.4535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-06 |
| Decision Date | 1983-10-04 |