ECI · Band, Elastic, Orthodontic
Dental · 21 CFR 872.5410 · Class 1
Overview
| Product Code | ECI |
|---|---|
| Device Name | Band, Elastic, 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 (25)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K980864 | POWER COINS GLOW IN THE DARK LIGATURES | Ortho Kinetics Corp. | Apr 20, 1998 | SESE |
| K980053 | GLENROE CHAIN | Glenroe Technologies | Feb 24, 1998 | SESE |
| K973495 | GLENROE GLOW IN DARK ELASTOMERIC LIGATURES | Glenroe | Dec 1, 1997 | SESE |
| K943419 | ORTHODONTIC ELASTOMERIC LAGATURE MODULE | Jon-Ko Products, Inc. | May 24, 1995 | SESE |
| K943420 | ORTHODONTIC ELASTOMERIC CHAIN | Jon-Ko Products, Inc. | May 23, 1995 | SESE |
| K943418 | ORTHODONTIC ELASTOMERIC SEPARATOR MODULE | Jon-Ko Products, Inc. | May 23, 1995 | SESE |
| K943417 | ORTHODONTIC ELASTOMERIC TUBE/THREAD | Jon-Ko Products, Inc. | May 23, 1995 | SESE |
| K940165 | ALASTIK | Unitek Corp. | Mar 7, 1994 | SESE |
| K932298 | PRO'S NEO-LASTICS | Professional Positioners, Inc. | Feb 14, 1994 | SESE |
| K935144 | DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS | Dentauraum, Inc. | Feb 4, 1994 | SESE |
| K932319 | ORTHODONTIC ELASTOMER | Gac Intl., Inc. | Sep 20, 1993 | SESE |
| K931462 | GLENROE CHAIN | Glenroe Technologies, Inc. | Jul 22, 1993 | SESE |
| K923999 | ALASTIK NS | Unitek Corp. | Jun 24, 1993 | SESE |
| K930453 | SINGLES | Nexadental | May 27, 1993 | SESE |
| K924140 | TUFF TIES | Glenroe Technologies | Apr 27, 1993 | SESE |
| K924139 | GLENROE ORTHO SEPS | Glenroe Technologies | Apr 8, 1993 | SESE |
| K926578 | UNI-STICK PLASTIC LIGATURE, MODIFIED | American Orthodontics | Mar 31, 1993 | SESE |
| K882695 | RUBBER BAND, STERILE | Bioseal | Oct 13, 1988 | SESE |
| K852600 | A-COMPANY ELASTOMERIC CHAIN DISPENSER | A Company, Inc. | Jul 31, 1985 | SESE |
| K852599 | A-COMPANY ELASTOMERIC TUBING | A Company, Inc. | Jul 31, 1985 | SESE |
| K852598 | A-COMPANY SEPARATING ELASTICS | A Company, Inc. | Jul 31, 1985 | SESE |
| K852597 | A-COMPANY ELASTIC ROTATION WEDGES | A Company, Inc. | Jul 31, 1985 | SESE |
| K852596 | A-COMPANY ELASTIC LIGATURE RINGS | A Company, Inc. | Jul 31, 1985 | SESE |
| K810010 | ORTHODONTIC ELASTICS | Orec Corp. | Jan 28, 1981 | SESE |
| K780804 | HYGIENIC ANCHORINGS | Hygienic Dental Mfg., Co., The | Jun 14, 1978 | SESE |
Top Applicants
- A Company, Inc. — 5 clearances
- Jon-Ko Products, Inc. — 4 clearances
- Glenroe Technologies — 3 clearances
- Unitek Corp. — 2 clearances
- Professional Positioners, Inc. — 1 clearance
