ECI — Band, Elastic, Orthodontic Class I
FDA Device Classification
Classification Details
- Product Code
- ECI
- Device Class
- Class I
- Regulation Number
- 872.5410
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K980864 | ortho kinetics | POWER COINS GLOW IN THE DARK LIGATURES | April 20, 1998 |
| K980053 | glenroe technologies | GLENROE CHAIN | February 24, 1998 |
| K973495 | glenroe | GLENROE GLOW IN DARK ELASTOMERIC LIGATURES | December 1, 1997 |
| K943419 | jon-ko products | ORTHODONTIC ELASTOMERIC LAGATURE MODULE | May 24, 1995 |
| K943420 | jon-ko products | ORTHODONTIC ELASTOMERIC CHAIN | May 23, 1995 |
| K943417 | jon-ko products | ORTHODONTIC ELASTOMERIC TUBE/THREAD | May 23, 1995 |
| K943418 | jon-ko products | ORTHODONTIC ELASTOMERIC SEPARATOR MODULE | May 23, 1995 |
| K940165 | unitek | ALASTIK | March 7, 1994 |
| K932298 | professional positioners | PRO'S NEO-LASTICS | February 14, 1994 |
| K935144 | dentauraum | DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS | February 4, 1994 |
| K932319 | gac intl | ORTHODONTIC ELASTOMER | September 20, 1993 |
| K931462 | glenroe technologies | GLENROE CHAIN | July 22, 1993 |
| K923999 | unitek | ALASTIK NS | June 24, 1993 |
| K930453 | nexadental | SINGLES | May 27, 1993 |
| K924140 | glenroe technologies | TUFF TIES | April 27, 1993 |
| K924139 | glenroe technologies | GLENROE ORTHO SEPS | April 8, 1993 |
| K926578 | american orthodontics | UNI-STICK PLASTIC LIGATURE, MODIFIED | March 31, 1993 |
| K882695 | bioseal | RUBBER BAND, STERILE | October 13, 1988 |
| K852599 | a company | A-COMPANY ELASTOMERIC TUBING | July 31, 1985 |
| K852596 | a company | A-COMPANY ELASTIC LIGATURE RINGS | July 31, 1985 |