MCF · Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
Dental · 21 CFR 872.6855 · Class 1
Overview
| Product Code | MCF |
|---|---|
| Device Name | Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile |
| Regulation | 21 CFR 872.6855 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K023662 | PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER | Hwadong International Company , Ltd. | May 28, 2003 | SESE |
| K021258 | GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER | Germ Terminator Corporation | May 10, 2002 | SESE |
| K003517 | OTRES TOOTHBRUSH SANITIZER MODEL TB100W | Otres, LLC | Jun 6, 2001 | SESE |
| K901459 | DS60 TOOTHBRUSH SANITIZER | Associated Mills, Inc. | Sep 17, 1990 | SESE |
| K896481 | PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER | Purebrush Assoc. | May 15, 1990 | SESE |
Top Applicants
- Associated Mills, Inc. — 1 clearance
- Germ Terminator Corporation — 1 clearance
- Hwadong International Company , Ltd. — 1 clearance
- Otres, LLC — 1 clearance
- Purebrush Assoc. — 1 clearance
