Device, Anti-Snoring
Regulation 872.5570
14510(k)s in 12 months (217 all time)
2recalls in 12 months (10 all time)
6recalls that name a 510(k)
Top companies in LRK
| Company | 510(k)s | Recalls |
|---|---|---|
| Somnomed, Inc. | 9 | 0 |
| Respire Medical | 3 | 5 |
| Sleeping Well, LLC | 6 | 0 |
| Prismatik Dentalcraft, Inc. | 4 | 1 |
| Airway Management, Inc. | 4 | 0 |
| Allen J. Moses, Dds, Ltd. | 4 | 0 |
| Always More Marketing | 4 | 0 |
| Medtronic Xomed, Inc. | 2 | 2 |
| Oventus Manufacturing Pty, Ltd. | 4 | 0 |
| Dental Imagineers, LLC | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 1997 | K972424 | SILENTNITE Glidewell Laboratories | LRK |
| Aug 25, 1997 | K972023 | SLEEP-IN BONE SCREW SYSTEM Influence, Inc. | LRK |
| Aug 21, 1997 | K972061 | TOA W. Keith Thornton, D.D.S. | LRK |
| Apr 14, 1997 | K963063 | SNORE TEC Marketing Technologies, Inc. | LRK |
| Jan 24, 1997 | K964516 | TAP Nellcor Puritan Bennett, Inc. | LRK |
| Sep 10, 1996 | K962516 | TAP ANTI-SNORING DEVICE Nellcor Puritan Bennett, Inc. | LRK |
| Mar 20, 1996 | K955822 | REMOVABLE HERBST APPLIANCE Univ. Dental Assoc. Department of Orthodontics | LRK |
| Jan 4, 1996 | K955336 | SNOREFREE Scott Feldman Dds & Norman Shapiro Dds | LRK |
| Oct 30, 1995 | K954530 | THE SILENCER Silent Knights Ventures, Inc., CA | LRK |
| Oct 17, 1995 | K954324 | SNOR-X MOUTH GUARD Snorex, Inc. | LRK |
| Oct 2, 1995 | K954128 | SNOREMASTER D.D.S., Inc. | LRK |
| May 25, 1995 | K950763 | LOWE KLEARWAY Dr. Alan A. Lowe, Inc., CA | LRK |
| Jul 8, 1993 | K926382 | THERASNORE Dr. Thomas E. Meade | LRK |
| Mar 31, 1993 | K922984 | ORTHODONTIC BITE American Orthodontics | LRK |
| Feb 9, 1990 | K895189 | ADJUSTABLE SOFT PALATE LIFTER Ortho Publications, Inc. | LRK |
| Apr 14, 1989 | K882303 | H&M ANTI-SNORING DEVICE Hays & Meade, Inc. | LRK |
| Oct 18, 1988 | K874416 | DENTAL ANTI-SNORING DEVICE Ortho Publications, Inc. | LRK |
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