DZL · Class II · 21 CFR 872.4880

FDA Product Code DZL: Screw, Fixation, Intraosseous

Under FDA product code DZL, intraosseous fixation screws are cleared for bone fixation in dental and maxillofacial surgery.

These titanium or resorbable screws are used to stabilize osteotomized or fractured bone segments of the jaws and craniofacial skeleton, providing rigid fixation that allows primary bone healing without movement at the repair site.

DZL devices are Class II medical devices, regulated under 21 CFR 872.4880 and reviewed by the FDA Dental panel.

Leading manufacturers include Synthes (Usa), Hager& Meisinger GmbH and Osteomed Corp..

81
Total
81
Cleared
150d
Avg days
1976
Since
81 devices
25–48 of 81
Cleared Mar 31, 2009
DRILL FREE MMF SCREW
K083432
KLS-Martin L.P.
Dental · 131d
Cleared Apr 06, 2005
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)
K050606
Synthes (Usa)
Dental · 27d
Cleared Apr 05, 2005
BONE BLOCK FIXATION SET
K050515
Straumann USA, Inc.
Dental · 35d
Cleared Mar 17, 2005
STRYKER MMF SCREW
K050535
Stryker Instruments
Dental · 15d
Cleared Oct 18, 2004
KLS MARTIN DRILL-FREE MMF SCREW
K042573
KLS-Martin L.P.
Dental · 27d
Cleared Aug 19, 2004
SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS
K041887
Synthes (Usa)
Dental · 38d
Cleared Jul 02, 2003
SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS
K031807
Synthes (Usa)
Dental · 21d
Cleared Aug 28, 2002
THE AUTOTAC SYSTEM TITANIUM TACK
K022790
BioHorizons Implant Systems, Inc.
Dental · 6d
Cleared Jun 10, 2002
SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS
K021850
Synthes (Usa)
Dental · 5d
Cleared May 21, 2002
LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW
K021522
Walter Lorenz Surgical, Inc.
Dental · 11d
Cleared Jan 16, 2002
OSTEOMED BIORESORBABLE FIXATION SYSTEM
K012486
Osteomed Corp.
Dental · 167d
Cleared Nov 28, 2001
BIOPLATE RESORBABLE BONE SCREW
K012908
Bioplate, Inc.
Dental · 90d
Cleared Jun 22, 2001
THE AUTOTAC SYSTEM
K011675
BioHorizons Implant Systems, Inc.
Dental · 23d
Cleared May 18, 2001
SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR
K010690
Synthes (Usa)
Dental · 71d
Cleared Apr 25, 2001
SYNTHES (USA) IMF SCREWS
K010527
Synthes (Usa)
Dental · 62d
Cleared Nov 16, 2000
SYNTHES 1.5MM TI BROW LIFT SCREW
K002935
Synthes (Usa)
Dental · 56d
Cleared Oct 20, 2000
LACTOSORB PUSH SCREW
K002423
Biomet, Inc.
Dental · 73d
Cleared Jan 07, 2000
THE AUTOTAC SYSTEM
K993493
BioHorizons Implant Systems, Inc.
Dental · 84d
Cleared Dec 29, 1999
RESOLVE QUICKANCHOR
K993575
Mitek Products
Dental · 69d
Cleared Dec 21, 1999
KLS-MARTIN MMF SCREW
K980760
KLS-Martin L.P.
Dental · 662d
Cleared Dec 16, 1999
TALON ANCHOR SNAP-PAK
K993327
Mitek Products
Dental · 73d
Cleared Nov 02, 1999
MITEK MINI ANCHOR
K992623
Mitek Products
Dental · 89d
Cleared Jun 21, 1999
IMTEC BIOPIN
K982951
Imtec Corp.
Dental · 301d
Cleared May 13, 1999
LORENZ IMF SCREW
K983728
Walter Lorenz Surgical, Inc.
Dental · 203d