ECM · Band, Preformed, Orthodontic
Dental · 21 CFR 872.5410 · Class 1
Overview
| Product Code | ECM |
|---|---|
| Device Name | Band, Preformed, Orthodontic |
| Regulation | 21 CFR 872.5410 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.
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.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K925163 | MICODOSE CHLORHEXIPREP | Unicep | May 27, 1993 | SESE |
| K872471 | TITANE SL DENTAL BURR | Titane SL Co. | Sep 11, 1987 | SESE |
Top Applicants
- Unicep — 1 clearance
- Titane SL Co. — 1 clearance
