JEW · Tip, Rubber, Oral Hygiene
Dental · 21 CFR 872.6650 · Class 1
Overview
| Product Code | JEW |
|---|---|
| Device Name | Tip, Rubber, Oral Hygiene |
| Regulation | 21 CFR 872.6650 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
A massaging pick or tip for oral hygiene is a rigid, pointed device intended to be used manually to stimulate and massage the gums to promote good periodontal (gum) condition.
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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K862635 | RABINOWITZ GUM MASSAGER | Arnell, Inc. | Sep 25, 1986 | SESE |
| K843406 | CHEW-DENT | Senair-Mot | Dec 11, 1984 | SESE |
| K790588 | ASSAY REAGENTS, LSA 290 | Kallestad Laboratories, Inc. | May 15, 1979 | SESE |
Top Applicants
- Senair-Mot — 1 clearance
- Kallestad Laboratories, Inc. — 1 clearance
- Arnell, Inc. — 1 clearance
