The following data is part of a premarket notification filed by Southland, Ltd. with the FDA for Southland Sterile Dental System.
| Device ID | K935127 |
| 510k Number | K935127 |
| Device Name: | SOUTHLAND STERILE DENTAL SYSTEM |
| Classification | Burnisher, Operative |
| Applicant | SOUTHLAND, LTD. 505 COMMERCE PARK DR. SUITE H Marietta, GA 30060 |
| Contact | Charles E Walker, Jr. |
| Correspondent | Charles E Walker, Jr. SOUTHLAND, LTD. 505 COMMERCE PARK DR. SUITE H Marietta, GA 30060 |
| Product Code | EKJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-28 |
| Decision Date | 1994-07-28 |