The following data is part of a premarket notification filed by Swiss American Metal Craft Corp. with the FDA for Jota Tungsten Carbide & Steel Dent. Burs.
| Device ID | K802988 |
| 510k Number | K802988 |
| Device Name: | JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS |
| Classification | Bur, Dental |
| Applicant | SWISS AMERICAN METAL CRAFT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJL |
| CFR Regulation Number | 872.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-21 |
| Decision Date | 1980-12-30 |