Sterilizer, Boiling Water
The Boiling Water Sterilizer is a dental device that uses boiling water to reduce the microbial burden on dental instruments, intended for use in settings where conventional autoclaving is impractical. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is ECG and the applicable regulation is 21 CFR 872.6710, under the Dental medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- ECG
- Device Class
- FDA class 1
- Regulation Number
- 872.6710
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K895164 | EAGLE DS | Nov 17, 1989 | Substantially Equivalent | American Sterilizer Co. |
| K843234 | CITOMAT AUTOCLAVES | Oct 25, 1984 | Substantially Equivalent | Lic-Orthion |
| K811237 | MAGNETIC RETENTION UNIT | Jun 16, 1981 | Substantially Equivalent | Universiti Malaya |
| K810977 | ENDODONTIC POST SYSTEMS | May 13, 1981 | Substantially Equivalent | Preat Corp. |
| K790290 | NEY EQUI-HINGE | Apr 10, 1979 | Substantially Equivalent | Deringer-Ney, Inc. |
| K790078 | BAR & RIDER, SCREWS, TUBES | Feb 27, 1979 | Substantially Equivalent | Eurodent, Inc. |
| K771266 | STEAM STERILIZER | Aug 02, 1977 | Substantially Equivalent | Amsco Hospital Products Co. |