DZD · Tube, Orthodontic
Dental · 21 CFR 872.5410 · Class 1
Overview
| Product Code | DZD |
|---|---|
| Device Name | Tube, 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 (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K943421 | ORTHODONITC ELASTOMERIC SLEEVING | Jon-Ko Products, Inc. | May 23, 1995 | SESE |
| K936243 | REGENCY TUBE | Ortho Specialties | Feb 2, 1994 | SESE |
| K935143 | DENTAURUM STAINLESS STEEL TUBING | Dentauraum, Inc. | Jan 31, 1994 | SESE |
| K911399 | NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) | Aequitron Medical, Inc. | Sep 19, 1991 | SESE |
| K896586 | RATE INCREASE FOR IPPB/IPV | Percussionaire Corp. | Jan 9, 1990 | SESE |
| K834446 | ALEXOTEK LINGUAL TUBES | Alexotek Co. | Apr 5, 1984 | SESE |
| K834392 | LABIAL CUSPID TUBE | Alexotek Co. | Feb 28, 1984 | SESE |
| K780205 | ORTHODONTIC BUCCAL TUBE | Rocky Mountain Orthodontics, Inc. | Feb 16, 1978 | SESE |
Top Applicants
- Alexotek Co. — 2 clearances
- Rocky Mountain Orthodontics, Inc. — 1 clearance
- Percussionaire Corp. — 1 clearance
- Ortho Specialties — 1 clearance
- Jon-Ko Products, Inc. — 1 clearance
