Stoma Bone Screw

510(k) Number

K051871 ↗

FDA product code

DZL

Device class

Class II

Regulation

21 CFR Part 872.4880

Advisory committee

Dental

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code DZL (Screw, Fixation, Intraosseous).

• Guided Bone Regeneration System by DentalMaster(Xiamen) Medical Technology Co., Ltd.
• OsteoMed 213-0001 by Osteomed Corp.
• OsteoMed 213-1640 by Osteomed Corp.
• BONE GRAFT SCREW SYSTEM by BICON, LLC
• GBR System SDS-160-060 by Surgident
• MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT by Hager& Meisinger GmbH
• SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS by Synthes (Usa)
• Leforte System Bone Screw 16-MD-010 by Jeil Medical Corporation
• Leforte System Bone Screw / GBR System Bone Screw 16-AT-007 by Jeil Medical Corporation
• USTOMED Bone Fixation/Bone Augmentation Systems - PIN by Ustomed Instrumente Ulrich Storz GmbH & Co. KG

• Kürette, Barnhart BH1-2, Ø 8mm

  Class I

  CE/MDR

• p.i.c.-tray, Basic Kit, Dr.Bergmann

  Class I

  CE/MDR

• Knochenspreizer, Memmingen

  Class I

  CE/MDR

• Knochenkürette mit Spülanschluss, Lucas, 3mm, gezahnt, DE

  Class I

  CE/MDR

See all devices from Storz am Mark GmbH →