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
Dec 21, 1998
SYNTHES 1.3 MM SELF-DRILLING SCREW
Synthes (Usa)
Dental
77d
Cleared
Dec 02, 1998
DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING
Doctor'S Research Group, Inc.
Dental
188d
Cleared
Nov 03, 1998
2.5 MM LACTOSORB SCREWS
Biomet, Inc.
Dental
176d
Cleared
Sep 08, 1998
QUICK TAP SELF DRILLING SCREW
Kinamed, Inc.
Dental
19d
Cleared
Jul 14, 1998
MEMBRANE TACK
Biomet, Inc.
Dental
82d
Cleared
Jun 29, 1998
SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR
Synthes (Usa)
Dental
75d
Cleared
Apr 17, 1998
SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS
Synthes (Usa)
Dental
87d
Cleared
Mar 13, 1998
DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM
Doctor'S Research Group, Inc.
Dental
80d
Cleared
Jan 30, 1998
LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM
Biovision GmbH
Dental
70d
Cleared
Dec 23, 1997
3I BIORESORBABLE FIXATION TACK
Implant Innovations, Inc.
Dental
175d
Cleared
Nov 18, 1997
IMTEC BONE TAC
Imtec Corp.
Dental
85d
Cleared
Nov 12, 1997
BONE GRAFT SCREW SYSTEM
Bicon, Inc.
Dental
89d
Cleared
Oct 10, 1997
OSTEOMED QUICKFIX
Osteomed Corp.
Dental
451d
Cleared
Jun 24, 1997
SMF TITANIUM (TI) ALLOY BONE SCREWS
Synthes (Usa)
Dental
292d
Cleared
Apr 11, 1997
SMF STAINLESS STEEL BONE SCREWS
Synthes (Usa)
Dental
168d
Cleared
Oct 25, 1996
OSTEOMED MSS
Osteomed Corp.
Dental
196d
Cleared
May 24, 1996
IMZ MEMBRANE TACK SYSTEM
Interpore Intl.
Dental
77d
Cleared
Jan 23, 1996
MEMFIX
The Straumann Co.
Dental
60d
Cleared
Jan 05, 1996
2.0 X 6MM SCREW
Brasseler USA I, L.P.
Dental
53d
Cleared
Nov 21, 1995
IMZ BONE TACK SYSTEM
Interpore Intl.
Dental
197d
Cleared
Aug 25, 1995
ACE BONE SCREW TACKING KIT
Ace Surgical Supply Co., Inc.
Dental
144d
Cleared
Sep 30, 1991
MEMFIX SCREWS
W.L. Gore & Associates, Inc.
Dental
241d
Cleared
Aug 21, 1991
OSTEOMED SBF SYSTEM (SBF)
Osteomed Corp.
Dental
112d
Cleared
Jan 28, 1977
LEW PROSTHETIC LOCKING DEVICE
Howmedica Corp.
Dental
7d