Product code LDS
- Device name
- Device, Pasteurization, Hot Water
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.6991
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183444 | Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector | Cenorin, LLC | 2019-09-09 |
| K031799 | MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 | Miele, Inc. | 2003-11-12 |
| K983068 | RELIANCE FAMILY OF WASHER-DISINFECTORS | STERIS Corporation | 2000-05-31 |
| K972193 | OLYMPIX MINI-PASTEURMATIC (58210) | Olympic Medical Corp. | 1997-09-05 |
| K950518 | MIELE G 7781 DENTAL THERMAL DISINFECTOR | Miele Professional | 1996-01-26 |
| K950566 | DECOMAT 4656 | Getinge Disinfection, Inc. | 1995-10-19 |
| K953645 | OLYMPIC PASTEURMATIC SYSTEM | Olympic Medical Corp. | 1995-09-22 |
| K884151 | MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU. | Miele Appliances, Inc. | 1989-05-16 |
| K860263 | CASTLE 7538 FLOOR LOADING WASHER | Castle Co. | 1986-03-05 |
| K844089 | CASTLE 7515 UTENSIL/GLASSWARE WASHER | Castle Co. | 1985-01-14 |
| K810311 | STERI-VERS | The Hilrad Co. | 1981-04-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07640397420406 | HIP Cleaning Solution | Dent4You AG | 2026-05-06 |
| 07640397420390 | HIP Ultra Cleaning Solution | Dent4You AG | 2026-05-06 |
| 07640397422332 | HIP Cleaning Solution | Dent4You AG | 2026-02-11 |
| 07640397422189 | HYDRIM 112W G4+ Instrument Washer | Dent4You AG | 2026-02-11 |
| 17640397422339 | HIP Cleaning Solution | Dent4You AG | 2026-02-11 |
| 07640397422349 | HYDRIM 112W G4+ Instrument Washer | Dent4You AG | 2026-02-11 |
| 07640397422356 | HYDRIM 112W G4+ Instrument Washer | Dent4You AG | 2026-02-11 |
| E308210050010 | Talos+ RIW-100TT | W & H STERILIZATION SRL | 2025-12-23 |
| E308210060010 | Talos+ RIW-100UC | W & H STERILIZATION SRL | 2025-12-23 |
| 07640397421915 | HYDRIM L110W Instrument Washer | Dent4You AG | 2025-01-15 |
| 07640397421960 | HYDRIM L110W G4 Instrument Washer | Dent4You AG | 2025-01-15 |
| 07640397421953 | HYDRIM L110W G4 Instrument Washer | Dent4You AG | 2025-01-15 |
| 07640397421946 | HYDRIM L110W G4 Instrument Washer | Dent4You AG | 2025-01-15 |
| 07640397421939 | HYDRIM L110W G4 Instrument Washer | Dent4You AG | 2025-01-15 |
| 07640397421922 | HYDRIM L110W Instrument Washer | Dent4You AG | 2025-01-15 |
| 07640397421908 | HYDRIM C61W G4 Instrument Washer | Dent4You AG | 2025-01-15 |
| 07640397421892 | HYDRIM C61W G4 Instrument Washer | Dent4You AG | 2025-01-15 |
| 07640397421885 | HYDRIM C61W G4 Instrument Washer | Dent4You AG | 2025-01-15 |
| 07290110640606 | TIVA2 TD | TUTTNAUER ISRAEL LTD. | 2023-06-20 |
| 07290110640613 | TIVA2-H TD | TUTTNAUER ISRAEL LTD. | 2023-06-20 |
| 07290110640880 | TIVA10-1V-HS-MD | TUTTNAUER ISRAEL LTD. | 2023-06-20 |
| 07290110640897 | TIVA10-2V-HS-MD | TUTTNAUER ISRAEL LTD. | 2023-06-20 |
| 07290110642013 | TIVA8-MD | TUTTNAUER ISRAEL LTD. | 2023-06-20 |
| 00852494007078 | Cenorin | CENORIN, L.L.C. | 2021-07-15 |
| 00852494007085 | Cenorin | CENORIN, L.L.C. | 2021-07-15 |
| 07540196001090 | HIP | Scican Ltd | 2020-11-09 |
| 07540196001083 | HIP Ultra | Scican Ltd | 2020-11-09 |
| 07540196001076 | HIP | Scican Ltd | 2020-11-09 |
| 07540196000017 | HYDRIM L110W G4 Instrument Washer | Scican Ltd | 2016-08-02 |
| 07540196000024 | HYDRIM L110W G4 Instrument Washer | Scican Ltd | 2016-08-02 |