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