Atlas FDA

DZL

80 FDA 510(k) clearances · Product code

109 daysmedian time to decision
300 days90th percentile
80clearances measured

FDA profile

Official device name
Screw, Fixation, Intraosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4880
Medical specialty
Dental
Flags
Implant
Adverse events (MAUDE)
2021: 55 · 2022: 162 · 2023: 100 · 2024: 106 · 2025: 71 · 2026: 41
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) (K250123)Hager& Meisinger GmbH2025-09-29
Bone Screw (K251569)Osstem Implant Co., Ltd.2025-08-13
USTOMED Bone Fixation/Bone Augmentation Systems - PIN (K243190)Ustomed Instrumente Ulrich Storz GmbH & Co. KG2025-06-27
GBR System (K233419)Proimtech Saglik Urunleri Anonim Sirketi2025-01-03
MP Pin flat without thread (36BMP000020/MP20) (K240321)Hager& Meisinger GmbH2024-10-17
KLS Martin Drill-Free MMF Screw (K233721)KLS-Martin L.P.2024-09-17
Stryker MP, Mandible, HMMF and MMF AXS Screws (K231599)Stryker Leibinger GmbH & Co KG2023-08-24
SAVE GBR (K222367)Dentis Co., Ltd.2023-03-23
The Micro Screw System, Micro Screw System Basic (K201210)Hager& Meisinger GmbH2021-10-08
Membrane Screws and Membrane Tacks (K201561)Neoss Limited2020-10-05
Bone Screw, Bone Tack (K182881)Osstem Implant Co., Ltd.2019-08-09
OssBuilder System (K181854)Osstem Implant Co., Ltd.2019-05-07
Intra-Lock Bone Fixation System (K171831)Intra-Lock International, Inc.2017-10-26
Salvin Tenting Screw System (K161857)Salvin Dental Specialties2017-04-28
Neo GBR System (K160991)Neobiotech Co., Ltd.2017-01-10
MC BIO Supertack Tack 3mm, 4mm and 5mm (K151540)Eli-Ka Technologies2016-05-26
OsteoMed IMF Screw (K151195)Osteomed2015-09-21
JUGGERKNOT MINI SOFT ANCHOR (K140908)Biomet Sports Medicine2014-10-02
DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL (K132212)Hager& Meisinger GmbH2014-02-14
MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT (K130682)Hager& Meisinger GmbH2013-08-13
NEODENT GRAFT SCREW (K103084)Jjgc Industria E Comercio DE Materiais Dentarios S2011-02-14
J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 (K101902)Jeil Medical Corporation2011-02-08
SALVIN DENTAL SPECIALTIES FIXATION SCREW (K100182)Salvin Dental Specialties, Inc.2010-05-10
PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# (K093719)Osteogenics Biomedical, Inc.2010-03-01
RAPIDSORB PLUS SCREW SYSTEM (K093464)Synthes (Usa)2010-01-25
MILTEX MEMBRANE TACK KIT (K092855)Miltex, Inc.2009-12-29
DRILL FREE MMF SCREW (K083432)KLS Martin L.P.2009-03-31
STOMA BONE BLOCK SCREW (K080430)Storz AM Mark GmbH2008-11-21
SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW (K073342)Salvin Dental Specialties, Inc.2008-03-26
ALPHA BIO BONE FIXATION SCREW SYSTEM (K063769)Alpha-Bio Tec , Ltd.2007-03-30
STOMA BONE SCREW (K051871)Storz AM Mark GmbH2005-10-27
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL) (K050606)Synthes (Usa)2005-04-06
BONE BLOCK FIXATION SET (K050515)Straumann USA, Inc.2005-04-05
STRYKER MMF SCREW (K050535)Stryker Instruments2005-03-17
KLS MARTIN DRILL-FREE MMF SCREW (K042573)KLS-Martin L.P.2004-10-18
SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS (K041887)Synthes (Usa)2004-08-19
SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS (K031807)Synthes (Usa)2003-07-02
THE AUTOTAC SYSTEM TITANIUM TACK (K022790)BioHorizons Implant Systems, Inc.2002-08-28
SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS (K021850)Synthes (Usa)2002-06-10
LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW (K021522)Walter Lorenz Surgical, Inc.2002-05-21
OSTEOMED BIORESORBABLE FIXATION SYSTEM (K012486)Osteomed Corp.2002-01-16
BIOPLATE RESORBABLE BONE SCREW (K012908)Bioplate, Inc.2001-11-28
THE AUTOTAC SYSTEM (K011675)BioHorizons Implant Systems, Inc.2001-06-22
SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR (K010690)Synthes (Usa)2001-05-18
SYNTHES (USA) IMF SCREWS (K010527)Synthes (Usa)2001-04-25
SYNTHES 1.5MM TI BROW LIFT SCREW (K002935)Synthes (Usa)2000-11-16
LACTOSORB PUSH SCREW (K002423)Biomet, Inc.2000-10-20
THE AUTOTAC SYSTEM (K993493)BioHorizons Implant Systems, Inc.2000-01-07
RESOLVE QUICKANCHOR (K993575)Mitek Products1999-12-29
KLS-MARTIN MMF SCREW (K980760)KLS-Martin L.P.1999-12-21
TALON ANCHOR SNAP-PAK (K993327)Mitek Products1999-12-16
MITEK MINI ANCHOR (K992623)Mitek Products1999-11-02
IMTEC BIOPIN (K982951)Imtec Corp.1999-06-21
LORENZ IMF SCREW (K983728)Walter Lorenz Surgical, Inc.1999-05-13
SYNTHES 1.3 MM SELF-DRILLING SCREW (K983485)Synthes (Usa)1998-12-21
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.1998-12-02
2.5 MM LACTOSORB SCREWS (K981666)Biomet, Inc.1998-11-03
QUICK TAP SELF DRILLING SCREW (K982927)Kinamed, Inc.1998-09-08
MEMBRANE TACK (K981459)Biomet, Inc.1998-07-14
SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR (K981362)Synthes (Usa)1998-06-29
SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS (K980199)Synthes (Usa)1998-04-17
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.1998-03-13
LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM (K974392)Biovision GmbH1998-01-30
3I BIORESORBABLE FIXATION TACK (K972480)Implant Innovations, Inc.1997-12-23
IMTEC BONE TAC (K973180)Imtec Corp.1997-11-18
BONE GRAFT SCREW SYSTEM (K973056)Bicon, Inc.1997-11-12
OSTEOMED QUICKFIX (K962774)Osteomed Corp.1997-10-10
SMF TITANIUM (TI) ALLOY BONE SCREWS (K963546)Synthes (Usa)1997-06-24
SMF STAINLESS STEEL BONE SCREWS (K964261)Synthes (Usa)1997-04-11
OSTEOMED MSS (K961418)Osteomed Corp.1996-10-25
IMZ MEMBRANE TACK SYSTEM (K960945)Interpore Intl.1996-05-24
MEMFIX (K955369)The Straumann Co.1996-01-23
2.0 X 6MM SCREW (K955140)Brasseler USA I, L.P.1996-01-05
IMZ BONE TACK SYSTEM (K952167)Interpore Intl.1995-11-21
ACE BONE SCREW TACKING KIT (K951510)Ace Surgical Supply Co., Inc.1995-08-25
MEMFIX SCREWS (K910427)W. L. Gore & Associates, Inc.1991-09-30
OSTEOMED SBF SYSTEM (SBF) (K911936)Osteomed Corp.1991-08-21
SCREW, BONE, MAXILLOFACIAL (K911165)Tekno-Medical1991-08-20
LEW PROSTHETIC LOCKING DEVICE (K770131)Howmedica Corp.1977-01-28
LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM (K761228)Howmedica Corp.1976-12-15

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