The following data is part of a premarket notification filed by Miele, Inc. with the FDA for Miele Dental Thermal Disinfector, Model G7881.
| Device ID | K031799 |
| 510k Number | K031799 |
| Device Name: | MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 |
| Classification | Device, Pasteurization, Hot Water |
| Applicant | MIELE, INC. 9 INDEPENDENCE WAY Princeton, NJ 08540 |
| Contact | Steve Polinski |
| Correspondent | Steve Polinski MIELE, INC. 9 INDEPENDENCE WAY Princeton, NJ 08540 |
| Product Code | LDS |
| CFR Regulation Number | 880.6991 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-10 |
| Decision Date | 2003-11-12 |
| Summary: | summary |