Tube, Orthodontic
Regulation 872.5410
0510(k)s in 12 months (8 all time)
0recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in DZD
| Company | 510(k)s | Recalls |
|---|---|---|
| Ormco/Sybronendo | 0 | 3 |
| Alexotek Co. | 2 | 0 |
| Aequitron Medical, Inc. | 1 | 0 |
| Dentauraum, Inc. | 1 | 0 |
| Jon-Ko Products, Inc. | 1 | 0 |
| Ortho Organizers Inc | 0 | 1 |
| Ortho Specialties | 1 | 0 |
| Percussionaire Corp. | 1 | 0 |
| Rocky Mountain Orthodontics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 23, 1995 | K943421 | ORTHODONITC ELASTOMERIC SLEEVING Jon-Ko Products, Inc. | DZD |
| Feb 2, 1994 | K936243 | REGENCY TUBE Ortho Specialties | DZD |
| Jan 31, 1994 | K935143 | DENTAURUM STAINLESS STEEL TUBING Dentauraum, Inc. | DZD |
| Sep 19, 1991 | K911399 | NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) Aequitron Medical, Inc. | DZD |
| Jan 9, 1990 | K896586 | RATE INCREASE FOR IPPB/IPV Percussionaire Corp. | DZD |
| Apr 5, 1984 | K834446 | ALEXOTEK LINGUAL TUBES Alexotek Co. | DZD |
| Feb 28, 1984 | K834392 | LABIAL CUSPID TUBE Alexotek Co. | DZD |
| Feb 16, 1978 | K780205 | ORTHODONTIC BUCCAL TUBE Rocky Mountain Orthodontics, Inc. | DZD |
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