DZHClass II
Saw, Bone, Ac-powered
Dental · 21 CFR 872.4120
MDR events37All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances4All time
Recent MDR events
37 adverse event reports on file
- INTRA-ORAL BLADESep 19, 2017MalfunctionStrykerMW5072218
- SAGGITAL SAW BLADE PRECISION THIN OFFSETApr 19, 2017MalfunctionStryker Corp6503013
- SAWBLADESJul 16, 2013InjuryBiomet Uk Ltd.3002806535-2013-00129
- MICRO OSCILLATING SAWDec 16, 2010MalfunctionStryker Instruments Kalamazoo1811755-2010-02051
- CORE INTRA-ORAL BLADEDec 8, 2010MalfunctionStryker Ireland Ltd.9616696-2010-00366
- CORE INTRA-ORAL BLADEJun 17, 2010MalfunctionStryker Ireland Ltd.9616696-2010-00250
- REPAIR TPS OSC SAWSep 22, 2009MalfunctionStryker Instruments Kalamazoo1811755-2009-00554
- CORE INTRA-ORAL BLADE;OSCILLATING 7MM SAW BLADEJul 11, 2009MalfunctionStryker Instruments1427149
- CORE INTRA-ORAL BLADEApr 3, 2009MalfunctionStryker Ireland Ltd9616696-2009-00036
- CORE INTRA-ORAL BLADEMar 14, 2009MalfunctionStryker1346534
Event type breakdown
Malfunction26
Injury11
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
4 clearances for this product code
- Dentatus USA , Ltd.Nov 13, 2003
K031793 · DENTATUS OSCIOMAT
- Osada Electric Co., Ltd.Sep 20, 1994
K935443 · ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS
- American Safety Equipment Corp.Nov 16, 1976
K760958 · SURGICAL OSCILLATING SAW
- American Safety Equipment Corp.Nov 15, 1976
K760957 · SURGICAL RECIPROCATING SAW