The following data is part of a premarket notification filed by Miele Professional with the FDA for Miele G 7781 Dental Thermal Disinfector.
| Device ID | K950518 | 
| 510k Number | K950518 | 
| Device Name: | MIELE G 7781 DENTAL THERMAL DISINFECTOR | 
| Classification | Device, Pasteurization, Hot Water | 
| Applicant | MIELE PROFESSIONAL 22 D WORLDS FAIR DR. Somerset, NJ 08852 | 
| Contact | Bernard Sessman | 
| Correspondent | Bernard Sessman MIELE PROFESSIONAL 22 D WORLDS FAIR DR. Somerset, NJ 08852 | 
| Product Code | LDS | 
| CFR Regulation Number | 880.6991 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1995-02-06 | 
| Decision Date | 1996-01-26 |