OYHClass II
Orthodontic Vibratory Accessory
Dental · 21 CFR 872.5470
An orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.
MDR events7All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances5All time
Recent MDR events
7 adverse event reports on file
- SURESMILE VPRO VIBRATION DEVICEJun 11, 2026MalfunctionDentsply Llc2424472-2026-00767
- HYPERBYTE VIBRATION DEVICEMar 6, 2026MalfunctionDentsply Llc2424472-2026-00596
- C-SHAPED VIBRATION DEVICESep 29, 2025InjuryDentsply LlcMW5176703
- HYPERBYTE VIBRATION DEVICEMay 19, 2025InjuryDentsply Llc2424472-2025-00222
- HYPERBYTE VIBRATION DEVICENov 22, 2024InjuryDentsply Llc2424472-2024-00406
- BYTE AT NIGHT ALIGNER KITMay 3, 2022InjuryByteMW5109502
- HYBERBYTEFeb 11, 2021MalfunctionStraight Smile, LlcMW5099361
Event type breakdown
Injury4
Malfunction3
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Propel Orthodontics, LLCNov 1, 2019
K183018 · VPro5
- Orthoaccel Technology, Inc.May 26, 2017
K170093 · AcceleDent Optima
- Orthoaccel Technologies, Inc.Jul 8, 2016
K153048 · AcceleDent Aura
- Orthoaccel Technologies, Inc.Apr 23, 2013
K130643 · ACCELEDENT AURA
- Orthoaccel Technologies, Inc.Nov 17, 2011
K110661 · ACCELEDENT