Product Code: DZL FDA class 2 21 CFR 872.4880

Screw, Fixation, Intraosseous

Dental

The Intraosseous Fixation Screw is a dental and oral surgical implant inserted into bone to stabilize jaw fractures, secure osteotomy segments, or anchor bone grafts during oral and maxillofacial surgical procedures. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DZL and the applicable regulation is 21 CFR 872.4880, under the Dental medical specialty. This device is an implant.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DZL
Device Class: FDA class 2
Regulation Number: 872.4880
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 80 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250123	Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)	Sep 29, 2025	Substantially Equivalent	Hager& Meisinger GmbH
K251569	Bone Screw	Aug 13, 2025	Substantially Equivalent	Osstem Implant Co., Ltd.
K243190	USTOMED Bone Fixation/Bone Augmentation Systems - PIN	Jun 27, 2025	Substantially Equivalent	Ustomed Instrumente Ulrich Storz GmbH & Co. KG
K233419	GBR System	Jan 03, 2025	Substantially Equivalent	Proimtech Saglik Urunleri Anonim Sirketi
K240321	MP Pin flat without thread (36BMP000020/MP20)	Oct 17, 2024	Substantially Equivalent	Hager& Meisinger GmbH
K233721	KLS Martin Drill-Free MMF Screw	Sep 17, 2024	Substantially Equivalent	KLS-Martin L.P.
K231599	Stryker MP, Mandible, HMMF and MMF AXS Screws	Aug 24, 2023	Substantially Equivalent	Stryker Leibinger GmbH & Co KG
K222367	SAVE GBR	Mar 23, 2023	Substantially Equivalent	Dentis Co., Ltd.
K201210	The Micro Screw System, Micro Screw System Basic	Oct 08, 2021	Substantially Equivalent	Hager& Meisinger GmbH
K201561	Membrane Screws and Membrane Tacks	Oct 05, 2020	Substantially Equivalent	Neoss Limited
K182881	Bone Screw, Bone Tack	Aug 09, 2019	Substantially Equivalent	Osstem Implant Co., Ltd.
K181854	OssBuilder System	May 07, 2019	Substantially Equivalent	Osstem Implant Co., Ltd.
K171831	Intra-Lock Bone Fixation System	Oct 26, 2017	Substantially Equivalent	Intra-Lock International, Inc.
K161857	Salvin Tenting Screw System	Apr 28, 2017	Substantially Equivalent	Salvin Dental Specialties
K160991	Neo GBR System	Jan 10, 2017	Substantially Equivalent	Neobiotech Co., Ltd.
K151540	MC BIO Supertack Tack 3mm, 4mm and 5mm	May 26, 2016	Substantially Equivalent	Eli-Ka Technologies
K151195	OsteoMed IMF Screw	Sep 21, 2015	Substantially Equivalent	Osteomed
K140908	JUGGERKNOT MINI SOFT ANCHOR	Oct 02, 2014	Substantially Equivalent	Biomet Sports Medicine
K132212	DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL	Feb 14, 2014	Substantially Equivalent	Hager& Meisinger GmbH
K130682	MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT	Aug 13, 2013	Substantially Equivalent	Hager& Meisinger GmbH
K103084	NEODENT GRAFT SCREW	Feb 14, 2011	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S
K101902	J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030	Feb 08, 2011	Substantially Equivalent	Jeil Medical Corporation
K100182	SALVIN DENTAL SPECIALTIES FIXATION SCREW	May 10, 2010	Substantially Equivalent	Salvin Dental Specialties, Inc.
K093719	PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#	Mar 01, 2010	Substantially Equivalent	Osteogenics Biomedical, Inc.
K093464	RAPIDSORB PLUS SCREW SYSTEM	Jan 25, 2010	Substantially Equivalent	Synthes (Usa)
K092855	MILTEX MEMBRANE TACK KIT	Dec 29, 2009	Substantially Equivalent	Miltex, Inc.
K083432	DRILL FREE MMF SCREW	Mar 31, 2009	Substantially Equivalent	KLS Martin L.P.
K080430	STOMA BONE BLOCK SCREW	Nov 21, 2008	Substantially Equivalent	Storz AM Mark GmbH
K073342	SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW	Mar 26, 2008	Substantially Equivalent	Salvin Dental Specialties, Inc.
K063769	ALPHA BIO BONE FIXATION SCREW SYSTEM	Mar 30, 2007	Substantially Equivalent	Alpha-Bio Tec , Ltd.
K051871	STOMA BONE SCREW	Oct 27, 2005	Substantially Equivalent	Storz AM Mark GmbH
K050606	SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)	Apr 06, 2005	Substantially Equivalent	Synthes (Usa)
K050515	BONE BLOCK FIXATION SET	Apr 05, 2005	Substantially Equivalent	Straumann USA, Inc.
K050535	STRYKER MMF SCREW	Mar 17, 2005	Substantially Equivalent	Stryker Instruments
K042573	KLS MARTIN DRILL-FREE MMF SCREW	Oct 18, 2004	Substantially Equivalent	KLS-Martin L.P.
K041887	SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS	Aug 19, 2004	Substantially Equivalent	Synthes (Usa)
K031807	SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS	Jul 02, 2003	Substantially Equivalent	Synthes (Usa)
K022790	THE AUTOTAC SYSTEM TITANIUM TACK	Aug 28, 2002	Substantially Equivalent	BioHorizons Implant Systems, Inc.
K021850	SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS	Jun 10, 2002	Substantially Equivalent	Synthes (Usa)
K021522	LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW	May 21, 2002	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K012486	OSTEOMED BIORESORBABLE FIXATION SYSTEM	Jan 16, 2002	Substantially Equivalent	Osteomed Corp.
K012908	BIOPLATE RESORBABLE BONE SCREW	Nov 28, 2001	Substantially Equivalent	Bioplate, Inc.
K011675	THE AUTOTAC SYSTEM	Jun 22, 2001	Substantially Equivalent	BioHorizons Implant Systems, Inc.
K010690	SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR	May 18, 2001	Substantially Equivalent	Synthes (Usa)
K010527	SYNTHES (USA) IMF SCREWS	Apr 25, 2001	Substantially Equivalent	Synthes (Usa)
K002935	SYNTHES 1.5MM TI BROW LIFT SCREW	Nov 16, 2000	Substantially Equivalent	Synthes (Usa)
K002423	LACTOSORB PUSH SCREW	Oct 20, 2000	Substantially Equivalent	Biomet, Inc.
K993493	THE AUTOTAC SYSTEM	Jan 07, 2000	Substantially Equivalent	BioHorizons Implant Systems, Inc.
K993575	RESOLVE QUICKANCHOR	Dec 29, 1999	Substantially Equivalent	Mitek Products
K980760	KLS-MARTIN MMF SCREW	Dec 21, 1999	Substantially Equivalent	KLS-Martin L.P.
K993327	TALON ANCHOR SNAP-PAK	Dec 16, 1999	Substantially Equivalent	Mitek Products
K992623	MITEK MINI ANCHOR	Nov 02, 1999	Substantially Equivalent	Mitek Products
K982951	IMTEC BIOPIN	Jun 21, 1999	Substantially Equivalent	Imtec Corp.
K983728	LORENZ IMF SCREW	May 13, 1999	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K983485	SYNTHES 1.3 MM SELF-DRILLING SCREW	Dec 21, 1998	Substantially Equivalent	Synthes (Usa)
K981881	DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING	Dec 02, 1998	Substantially Equivalent	Doctor'S Research Group, Inc.
K981666	2.5 MM LACTOSORB SCREWS	Nov 03, 1998	Substantially Equivalent	Biomet, Inc.
K982927	QUICK TAP SELF DRILLING SCREW	Sep 08, 1998	Substantially Equivalent	Kinamed, Inc.
K981459	MEMBRANE TACK	Jul 14, 1998	Substantially Equivalent	Biomet, Inc.
K981362	SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR	Jun 29, 1998	Substantially Equivalent	Synthes (Usa)
K980199	SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS	Apr 17, 1998	Substantially Equivalent	Synthes (Usa)
K974817	DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM	Mar 13, 1998	Substantially Equivalent	Doctor'S Research Group, Inc.
K974392	LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM	Jan 30, 1998	Substantially Equivalent	Biovision GmbH
K972480	3I BIORESORBABLE FIXATION TACK	Dec 23, 1997	Substantially Equivalent	Implant Innovations, Inc.
K973180	IMTEC BONE TAC	Nov 18, 1997	Substantially Equivalent	Imtec Corp.
K973056	BONE GRAFT SCREW SYSTEM	Nov 12, 1997	Substantially Equivalent	Bicon, Inc.
K962774	OSTEOMED QUICKFIX	Oct 10, 1997	Substantially Equivalent	Osteomed Corp.
K963546	SMF TITANIUM (TI) ALLOY BONE SCREWS	Jun 24, 1997	Substantially Equivalent	Synthes (Usa)
K964261	SMF STAINLESS STEEL BONE SCREWS	Apr 11, 1997	Substantially Equivalent	Synthes (Usa)
K961418	OSTEOMED MSS	Oct 25, 1996	Substantially Equivalent	Osteomed Corp.
K960945	IMZ MEMBRANE TACK SYSTEM	May 24, 1996	Substantially Equivalent	Interpore Intl.
K955369	MEMFIX	Jan 23, 1996	Substantially Equivalent	The Straumann Co.
K955140	2.0 X 6MM SCREW	Jan 05, 1996	Substantially Equivalent	Brasseler USA I, L.P.
K952167	IMZ BONE TACK SYSTEM	Nov 21, 1995	Substantially Equivalent	Interpore Intl.
K951510	ACE BONE SCREW TACKING KIT	Aug 25, 1995	Substantially Equivalent	Ace Surgical Supply Co., Inc.
K910427	MEMFIX SCREWS	Sep 30, 1991	Substantially Equivalent	W. L. Gore & Associates, Inc.
K911936	OSTEOMED SBF SYSTEM (SBF)	Aug 21, 1991	Substantially Equivalent	Osteomed Corp.
K911165	SCREW, BONE, MAXILLOFACIAL	Aug 20, 1991	Substantially Equivalent	Tekno-Medical
K770131	LEW PROSTHETIC LOCKING DEVICE	Jan 28, 1977	Substantially Equivalent	Howmedica Corp.
K761228	LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM	Dec 15, 1976	Substantially Equivalent	Howmedica Corp.