The following data is part of a premarket notification filed by Star Dental Mfg. Co. with the FDA for Rotary Scaler.
| Device ID | K782007 |
| 510k Number | K782007 |
| Device Name: | ROTARY SCALER |
| Classification | Scaler, Rotary |
| Applicant | STAR DENTAL MFG. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELB |
| CFR Regulation Number | 872.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-01 |
| Decision Date | 1979-01-03 |