ECG · Sterilizer, Boiling Water
Dental · 21 CFR 872.6710 · Class 1
Overview
| Product Code | ECG |
|---|---|
| Device Name | Sterilizer, Boiling Water |
| Regulation | 21 CFR 872.6710 |
| Device Class | Class 1 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A boiling water sterilizer is an AC-powered device that consists of a container for boiling water. The device is intended to sterilize dental and surgical instruments by submersion in the boiling water in the container.
Classification Rationale
Class I (general controls).
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K895164 | EAGLE DS | American Sterilizer Co. | Nov 17, 1989 | SESE |
| K843234 | CITOMAT AUTOCLAVES | Lic-Orthion | Oct 25, 1984 | SESE |
| K811237 | MAGNETIC RETENTION UNIT | Universiti Malaya | Jun 16, 1981 | SESE |
| K810977 | ENDODONTIC POST SYSTEMS | Preat Corp. | May 13, 1981 | SESE |
| K790290 | NEY EQUI-HINGE | Deringer-Ney, Inc. | Apr 10, 1979 | SESE |
| K790078 | BAR & RIDER, SCREWS, TUBES | Eurodent, Inc. | Feb 27, 1979 | SESE |
| K771266 | STEAM STERILIZER | Amsco Hospital Products Co. | Aug 2, 1977 | SESE |
Top Applicants
- Universiti Malaya — 1 clearance
- Preat Corp. — 1 clearance
- Lic-Orthion — 1 clearance
- Eurodent, Inc. — 1 clearance
- Deringer-Ney, Inc. — 1 clearance
