The following data is part of a premarket notification filed by Dentalez Group with the FDA for Stardental Axcs Sterile Water System.
| Device ID | K990844 |
| 510k Number | K990844 |
| Device Name: | STARDENTAL AXCS STERILE WATER SYSTEM |
| Classification | Unit, Operative Dental |
| Applicant | DENTALEZ GROUP 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Contact | Frank Oellig |
| Correspondent | Frank Oellig DENTALEZ GROUP 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-15 |
| Decision Date | 1999-05-28 |
| Summary: | summary |