KXR · Applicator, Resin
Dental · 21 CFR 872.3140 · Class 1
Overview
| Product Code | KXR |
|---|---|
| Device Name | Applicator, Resin |
| Regulation | 21 CFR 872.3140 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
A resin applicator is a brushlike device intended for use in spreading dental resin on a tooth during application of tooth shade material.
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, the device 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 |
|---|---|---|---|---|
| K832662 | DENTAL SYRINGE SYSTEM-VARIOUS STYLES | Centrix, Inc. | Oct 4, 1983 | SESE |
| K781098 | BRUSH, APPLICATOR | 3M Company | Sep 29, 1978 | SESE |
| K770160 | CERAMIST BRUSH | Deringer-Ney, Inc. | Jan 31, 1977 | SESE |
Top Applicants
- 3M Company — 1 clearance
- Centrix, Inc. — 1 clearance
- Deringer-Ney, Inc. — 1 clearance
