EJF · Bracket, Metal, Orthodontic
Dental · 21 CFR 872.5410 · Class 1
Overview
| Product Code | EJF |
|---|---|
| Device Name | Bracket, Metal, 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.
Recent Cleared Devices (20 of 103)
Showing 20 most recent of 103 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K994357 | BITEM LOCK, MODELS SW006, SW012 | Thermoelastic Technologies, Inc. | Mar 14, 2000 | SESE |
| K932825 | MICROARCH GOLD BRACKET | Gac Intl., Inc. | May 9, 1994 | SESE |
| K933501 | ALASTIK | Unitek Corp. | Apr 28, 1994 | SESE |
| K923372 | MEMORY WIRE | Althan, Inc. | Apr 22, 1994 | SESE |
| K933080 | ORTHOTECH DURA-GOLD BARCKETS | Orthotech | Mar 23, 1994 | SESE |
| K935139 | FASCINATION CERAMIC BRACKET | Dentauraum, Inc. | Feb 4, 1994 | SESE |
| K936244 | REGENCY BRACKET | Mid-American Dental Specialties, Inc. | Feb 2, 1994 | SESE |
| K934881 | REFLECTIONS | Cdb Corp. | Feb 1, 1994 | SESE |
| K935122 | DENTAURUM METAL BRACKETS | Dentauraum, Inc. | Jan 31, 1994 | SESE |
| K926427 | LARIAT PALATE EXPANDER | Easy Access Orthodontics, Inc. | Jan 26, 1994 | SESE |
| K925028 | FORESTADENT ORTHODONTIC BANDS | Forestadent | Jan 26, 1994 | SESE |
| K930881 | CHANNEL-EDGE BRACKET SYSTEM | Dualtek, Inc. | Jan 21, 1994 | SESE |
| K933758 | REGENCY PLUS BRACKET | Mid-American Dental Specialties, Inc. | Jan 18, 1994 | SESE |
| K922806 | ORMCO SPORTSGUARD | Ormco Corp. | Oct 20, 1993 | SESE |
| K932025 | ION-IMPLANTED NEO SENTALLOY | Gac Intl., Inc. | Sep 13, 1993 | SESE |
| K925012 | PLASTIC CHAIN | American Orthodontics | Sep 13, 1993 | SESE |
| K923218 | NITANIUM PALATAL EXPANDER | Ortho Organizers, Inc. | Sep 13, 1993 | SESE |
| K931663 | NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL | Ortho Organizers, Inc. | Jul 8, 1993 | SESE |
| K930452 | SOLO TIES | Zulaf, Inc. | Jul 8, 1993 | SESE |
| K924971 | FORESTADENT BRACKETS | Forestadent Bernhard Forster GmbH | May 27, 1993 | SESE |
Top Applicants
- American Orthodontics — 22 clearances
- Ormco Corp. — 8 clearances
- Flexmedics — 7 clearances
- Lancer Orthodontics, Inc. — 7 clearances
- Gac Intl., Inc. — 5 clearances
