Product code MQC ยท Class U
Mouthguard, Prescription
3510(k)s in 12 months (72 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in MQC
| Company | 510(k)s | Recalls |
|---|---|---|
| Pro3Dure Medical | 4 | 0 |
| Dental Concepts, LLC | 2 | 0 |
| Envisiontec GmbH | 2 | 0 |
| Formlabs Ohio, Inc. | 2 | 0 |
| Keystone Industries | 1 | 1 |
| Power Products, Inc.-Splintek | 2 | 0 |
| Prismatik Dentalcraft, Inc. | 2 | 0 |
| Whip Mix Corporation | 2 | 0 |
| 12th Man Technologies, Inc. | 1 | 0 |
| 3D Diagnostix, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 13, 2011 | K102909 | SOMNOBRUX SPLINTS Somnomed, Inc. | MQC |
| Nov 22, 2011 | K111066 | MIGRA TAB, QUICKSPLINT MIGRAINE Migratherapy, LLC | MQC |
| Oct 26, 2011 | K111828 | CLEARSPLINT ES Astron Dental Corporation | MQC |
| Aug 5, 2011 | K110468 | FREEWAY COMFORT BITE GUARD Randmark Dental Products, LLC | MQC |
| Feb 24, 2010 | K091880 | CLAYTON INTRA-AURAL DEVICE (CID) Ascentia Health Incorporated | MQC |
| Oct 14, 2009 | K090472 | GRIND GUARD Archtek, Inc. | MQC |
| Aug 31, 2009 | K082723 | GRINDGUARD Grind Guard Technologies, LLC | MQC |
| Nov 16, 2007 | K072522 | THERMOFORM SHEET MATERIALS AND ACCESSORIES Dentsply International, Inc. | MQC |
| Aug 17, 2007 | K071404 | SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE Power Products, Inc.-Splintek | MQC |
| Mar 12, 2007 | K061122 | NIGHT GUARD Alpine Oral Care, LLC | MQC |
| Jan 23, 2007 | K063483 | DEN TEK NIGHTGUARD Den Tek Oral Care, Inc. | MQC |
| Nov 27, 2006 | K062828 | MOUTHGUARD AND ALIGNER MATERIALS Dentsply Intl., Inc. | MQC |
| Mar 3, 2006 | K053580 | DOCTOR'S NIGHTGUARD Dental Concepts, LLC | MQC |
| Aug 27, 2004 | K040315 | MYOHEALTH CLENCHING INHIBITOR Mci-Myohealth Systems | MQC |
| Oct 17, 2003 | K022809 | EZ SPLINT & EZ SPLINT PM Power Products, Inc.-Splintek | MQC |
| Sep 17, 2003 | K030832 | PRIMOSPLINT SYSTEM Cosmedent, Inc. | MQC |
| Mar 26, 2003 | K024261 | DENTAL PROTECTOR Dental Concepts, LLC | MQC |
| Mar 18, 2003 | K022627 | DSG RELAXER SPLINT Sentage Corporation D/B/A/ Dental Services Group | MQC |
| Feb 22, 2002 | K014079 | DR. HAYS BITE GUARD Inventive Resources, Inc. | MQC |
| Oct 7, 1998 | K980953 | ACCU-BITE HOME KIT DISCLUDER Jerome M. Simon | MQC |
| Jul 15, 1998 | K981546 | NTI CLENCHING SUPPRESSION SYSTEM Heraeus Kulzer, Inc. | MQC |
| Mar 8, 1996 | K955701 | NIGHTGUARD DIAGNOSTIC APPLIANCE Cycura Corp. | MQC |
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