The following data is part of a premarket notification filed by Medishield, Inc. with the FDA for Air-pwoered Coldrill.
| Device ID | K780646 |
| 510k Number | K780646 |
| Device Name: | AIR-PWOERED COLDRILL |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | MEDISHIELD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-17 |
| Decision Date | 1978-04-28 |