Band, Elastic, Orthodontic
The Elastic Orthodontic Band is a small, stretchable ring placed around individual teeth or used between brackets to apply light, continuous forces that assist in tooth movement and space closure during orthodontic treatment. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is ECI and the applicable regulation is 21 CFR 872.5410, under the Dental medical specialty.
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Basic Information
- Product Code
- ECI
- Device Class
- FDA class 1
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 25 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K980864 | POWER COINS GLOW IN THE DARK LIGATURES | Apr 20, 1998 | Substantially Equivalent | Ortho Kinetics Corp. |
| K980053 | GLENROE CHAIN | Feb 24, 1998 | Substantially Equivalent | Glenroe Technologies |
| K973495 | GLENROE GLOW IN DARK ELASTOMERIC LIGATURES | Dec 01, 1997 | Substantially Equivalent | Glenroe |
| K943419 | ORTHODONTIC ELASTOMERIC LAGATURE MODULE | May 24, 1995 | Substantially Equivalent | Jon-Ko Products, Inc. |
| K943420 | ORTHODONTIC ELASTOMERIC CHAIN | May 23, 1995 | Substantially Equivalent | Jon-Ko Products, Inc. |
| K943418 | ORTHODONTIC ELASTOMERIC SEPARATOR MODULE | May 23, 1995 | Substantially Equivalent | Jon-Ko Products, Inc. |
| K943417 | ORTHODONTIC ELASTOMERIC TUBE/THREAD | May 23, 1995 | Substantially Equivalent | Jon-Ko Products, Inc. |
| K940165 | ALASTIK | Mar 07, 1994 | Substantially Equivalent | Unitek Corp. |
| K932298 | PRO'S NEO-LASTICS | Feb 14, 1994 | Substantially Equivalent | Professional Positioners, Inc. |
| K935144 | DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS | Feb 04, 1994 | Substantially Equivalent | Dentauraum, Inc. |
| K932319 | ORTHODONTIC ELASTOMER | Sep 20, 1993 | Substantially Equivalent | Gac Intl., Inc. |
| K931462 | GLENROE CHAIN | Jul 22, 1993 | Substantially Equivalent | Glenroe Technologies, Inc. |
| K923999 | ALASTIK NS | Jun 24, 1993 | Substantially Equivalent | Unitek Corp. |
| K930453 | SINGLES | May 27, 1993 | Substantially Equivalent | Nexadental |
| K924140 | TUFF TIES | Apr 27, 1993 | Substantially Equivalent | Glenroe Technologies |
| K924139 | GLENROE ORTHO SEPS | Apr 08, 1993 | Substantially Equivalent | Glenroe Technologies |
| K926578 | UNI-STICK PLASTIC LIGATURE, MODIFIED | Mar 31, 1993 | Substantially Equivalent | American Orthodontics |
| K882695 | RUBBER BAND, STERILE | Oct 13, 1988 | Substantially Equivalent | Bioseal |
| K852600 | A-COMPANY ELASTOMERIC CHAIN DISPENSER | Jul 31, 1985 | Substantially Equivalent | A Company, Inc. |
| K852599 | A-COMPANY ELASTOMERIC TUBING | Jul 31, 1985 | Substantially Equivalent | A Company, Inc. |
| K852598 | A-COMPANY SEPARATING ELASTICS | Jul 31, 1985 | Substantially Equivalent | A Company, Inc. |
| K852597 | A-COMPANY ELASTIC ROTATION WEDGES | Jul 31, 1985 | Substantially Equivalent | A Company, Inc. |
| K852596 | A-COMPANY ELASTIC LIGATURE RINGS | Jul 31, 1985 | Substantially Equivalent | A Company, Inc. |
| K810010 | ORTHODONTIC ELASTICS | Jan 28, 1981 | Substantially Equivalent | Orec Corp. |
| K780804 | HYGIENIC ANCHORINGS | Jun 14, 1978 | Substantially Equivalent | Hygienic Dental Mfg., Co., The |
FEI Numbers
This FDA classification entry is associated with 118 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 118 registration numbers. Click on an entry to view related FDA registrations.