Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
The sterile ultraviolet sanitation/sterilization unit for toothbrushes is a dental hygiene device that uses UV light to reduce or eliminate microbial contamination on toothbrush bristles between uses. It is classified as FDA Class I under 21 CFR 872.6855 within the Dental specialty, subject only to general controls. The product code is MCF and the device is not GMP-exempt. It is not implanted and does not sustain life.
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Basic Information
- Product Code
- MCF
- Device Class
- FDA class 1
- Regulation Number
- 872.6855
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K023662 | PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER | May 28, 2003 | Substantially Equivalent | Hwadong International Company , Ltd. |
| K021258 | GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER | May 10, 2002 | Substantially Equivalent | Germ Terminator Corporation |
| K003517 | OTRES TOOTHBRUSH SANITIZER MODEL TB100W | Jun 06, 2001 | Substantially Equivalent | Otres, LLC |
| K901459 | DS60 TOOTHBRUSH SANITIZER | Sep 17, 1990 | Substantially Equivalent | Associated Mills, Inc. |
| K896481 | PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER | May 15, 1990 | Substantially Equivalent | Purebrush Assoc. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.