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
49–72 of 81
Cleared Dec 21, 1998
SYNTHES 1.3 MM SELF-DRILLING SCREW
K983485
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
K981881
Doctor'S Research Group, Inc.
Dental · 188d
Cleared Nov 03, 1998
2.5 MM LACTOSORB SCREWS
K981666
Biomet, Inc.
Dental · 176d
Cleared Sep 08, 1998
QUICK TAP SELF DRILLING SCREW
K982927
Kinamed, Inc.
Dental · 19d
Cleared Jul 14, 1998
MEMBRANE TACK
K981459
Biomet, Inc.
Dental · 82d
Cleared Jun 29, 1998
SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR
K981362
Synthes (Usa)
Dental · 75d
Cleared Apr 17, 1998
SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS
K980199
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
K974817
Doctor'S Research Group, Inc.
Dental · 80d
Cleared Jan 30, 1998
LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM
K974392
Biovision GmbH
Dental · 70d
Cleared Dec 23, 1997
3I BIORESORBABLE FIXATION TACK
K972480
Implant Innovations, Inc.
Dental · 175d
Cleared Nov 18, 1997
IMTEC BONE TAC
K973180
Imtec Corp.
Dental · 85d
Cleared Nov 12, 1997
BONE GRAFT SCREW SYSTEM
K973056
Bicon, Inc.
Dental · 89d
Cleared Oct 10, 1997
OSTEOMED QUICKFIX
K962774
Osteomed Corp.
Dental · 451d
Cleared Jun 24, 1997
SMF TITANIUM (TI) ALLOY BONE SCREWS
K963546
Synthes (Usa)
Dental · 292d
Cleared Apr 11, 1997
SMF STAINLESS STEEL BONE SCREWS
K964261
Synthes (Usa)
Dental · 168d
Cleared Oct 25, 1996
OSTEOMED MSS
K961418
Osteomed Corp.
Dental · 196d
Cleared May 24, 1996
IMZ MEMBRANE TACK SYSTEM
K960945
Interpore Intl.
Dental · 77d
Cleared Jan 23, 1996
MEMFIX
K955369
The Straumann Co.
Dental · 60d
Cleared Jan 05, 1996
2.0 X 6MM SCREW
K955140
Brasseler USA I, L.P.
Dental · 53d
Cleared Nov 21, 1995
IMZ BONE TACK SYSTEM
K952167
Interpore Intl.
Dental · 197d
Cleared Aug 25, 1995
ACE BONE SCREW TACKING KIT
K951510
Ace Surgical Supply Co., Inc.
Dental · 144d
Cleared Sep 30, 1991
MEMFIX SCREWS
K910427
W.L. Gore & Associates, Inc.
Dental · 241d
Cleared Aug 21, 1991
OSTEOMED SBF SYSTEM (SBF)
K911936
Osteomed Corp.
Dental · 112d
Cleared Jan 28, 1977
LEW PROSTHETIC LOCKING DEVICE
K770131
Howmedica Corp.
Dental · 7d