QJC · Plaque Disclosing Agent
Dental · 21 CFR 872.6855 · Class 1
Overview
| Product Code | QJC |
|---|---|
| Device Name | Plaque Disclosing Agent |
| 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K770990 | DENTAL PLAQUE DISCLOSING AGENT | Evident Dental Co. , Ltd. | Jun 20, 1977 | SESE |
Top Applicants
- Evident Dental Co. , Ltd. — 1 clearance
