Band, Elastic, Orthodontic
Regulation 872.5410
0510(k)s in 12 months (25 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in ECI
| Company | 510(k)s | Recalls |
|---|---|---|
| A Company, Inc. | 5 | 0 |
| Glenroe Technologies | 4 | 0 |
| Jon-Ko Products, Inc. | 4 | 0 |
| G & H Wire Company | 0 | 2 |
| Unitek Corp. | 2 | 0 |
| American Orthodontics | 1 | 0 |
| Biomet Microfixation, Inc. | 0 | 1 |
| Bioseal | 1 | 0 |
| Dentauraum, Inc. | 1 | 0 |
| Gac Intl., Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 20, 1998 | K980864 | POWER COINS GLOW IN THE DARK LIGATURES Ortho Kinetics Corp. | ECI |
| Feb 24, 1998 | K980053 | GLENROE CHAIN Glenroe Technologies | ECI |
| Dec 1, 1997 | K973495 | GLENROE GLOW IN DARK ELASTOMERIC LIGATURES Glenroe | ECI |
| May 24, 1995 | K943419 | ORTHODONTIC ELASTOMERIC LAGATURE MODULE Jon-Ko Products, Inc. | ECI |
| May 23, 1995 | K943420 | ORTHODONTIC ELASTOMERIC CHAIN Jon-Ko Products, Inc. | ECI |
| May 23, 1995 | K943418 | ORTHODONTIC ELASTOMERIC SEPARATOR MODULE Jon-Ko Products, Inc. | ECI |
| May 23, 1995 | K943417 | ORTHODONTIC ELASTOMERIC TUBE/THREAD Jon-Ko Products, Inc. | ECI |
| Mar 7, 1994 | K940165 | ALASTIK Unitek Corp. | ECI |
| Feb 14, 1994 | K932298 | PRO'S NEO-LASTICS Professional Positioners, Inc. | ECI |
| Feb 4, 1994 | K935144 | DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS Dentauraum, Inc. | ECI |
| Sep 20, 1993 | K932319 | ORTHODONTIC ELASTOMER Gac Intl., Inc. | ECI |
| Jul 22, 1993 | K931462 | GLENROE CHAIN Glenroe Technologies, Inc. | ECI |
| Jun 24, 1993 | K923999 | ALASTIK NS Unitek Corp. | ECI |
| May 27, 1993 | K930453 | SINGLES Nexadental | ECI |
| Apr 27, 1993 | K924140 | TUFF TIES Glenroe Technologies | ECI |
| Apr 8, 1993 | K924139 | GLENROE ORTHO SEPS Glenroe Technologies | ECI |
| Mar 31, 1993 | K926578 | UNI-STICK PLASTIC LIGATURE, MODIFIED American Orthodontics | ECI |
| Oct 13, 1988 | K882695 | RUBBER BAND, STERILE Bioseal | ECI |
| Jul 31, 1985 | K852600 | A-COMPANY ELASTOMERIC CHAIN DISPENSER A Company, Inc. | ECI |
| Jul 31, 1985 | K852599 | A-COMPANY ELASTOMERIC TUBING A Company, Inc. | ECI |
| Jul 31, 1985 | K852598 | A-COMPANY SEPARATING ELASTICS A Company, Inc. | ECI |
| Jul 31, 1985 | K852597 | A-COMPANY ELASTIC ROTATION WEDGES A Company, Inc. | ECI |
| Jul 31, 1985 | K852596 | A-COMPANY ELASTIC LIGATURE RINGS A Company, Inc. | ECI |
| Jan 28, 1981 | K810010 | ORTHODONTIC ELASTICS Orec Corp. | ECI |
| Jun 14, 1978 | K780804 | HYGIENIC ANCHORINGS Hygienic Dental Mfg., Co., The | ECI |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.