Atlas FDA

NHA

713 FDA 510(k) clearances · Product code

141 daysmedian time to decision
304 days90th percentile
713clearances measured

FDA profile

Official device name
Abutment, Implant, Dental, Endosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3630
Medical specialty
Dental
Flags
Implant
FDA definition
To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Adverse events (MAUDE)
2021: 546 · 2022: 497 · 2023: 618 · 2024: 636 · 2025: 850 · 2026: 1,481
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw (K253999)Nobel Biocare AB2026-08-06
Neodent Implant System - NeoConvert Fit (K261147)JJGC Indústria e Comércio de Materiais Dentários S.A.2026-07-01
MIST IC (K261122)Imagine Milling Technologies, LLC2026-06-27
BioHorizons CEREC Compatible Ti-Bases (K260061)BioHorizons Implant Systems, Inc.2026-06-26
Neodent Scannable Healing Abutment (K253922)JJGC Indústria e Comércio de Materiais Dentários S.A.2026-06-15
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (K254145)Smart Denture Conversions, LLC2026-06-11
DESS Dental Smart Solutions (K260564)Terrats Medical SL2026-06-09
SIC Abutments including CAD/CAM Solutions (K252904)Sic Invent AG2026-06-03
Elos Accurate® Denture Fixation System (K253774)Elos Medtech Pinol A/S2026-05-20
ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments (K253372)Hiossen, Inc.2026-05-14
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue (K260460)Institut Straumann AG2026-05-07
DESS Dental Smart Solutions (K253804)Terrats Medical SL2026-04-16
LOCATOR® Angled Abutment (K260555)Zest Anchors, LLC2026-04-09
Healing Abutment System (K251434)Osstem Implant Co., Ltd.2026-03-04
Solidex® Ti-Links and Screws (K251515)CreoDent Hudson Valley2026-02-10
EK MULTI ANGLED 30 ABUTMENT (K251427)Hiossen, Inc.2026-01-29
Multi-Unit DAS System (K243732)Talladium España, SL2026-01-29
IPDmilled Blanks (K253253)Implant Protesis Dental 2004, S.L.2026-01-22
Straumann Variobase Abutments XC for Bridge/Bar (K253315)Institut Straumann AG2026-01-22
Neodent InLab Validated Workflow (K252727)JJGC Indústria e Comércio de Materiais Dentários S.A.2026-01-07
Custom Abutments AS (K253341)Medentika GmbH2025-12-23
OrangeCAD Med Abutments (K253312)Orangecad Med GmbH2025-12-23
SIMDA Abutments (K252320)Simda Co., Ltd.2025-12-18
Atlantis® Abutments in Titanium (K252343)Dentsply Sirona2025-12-09
CEREC Tessera Abutment System (K252248)Dentsply Sirona2025-11-26
Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants (K251205)Dentsply Sirona2025-11-21
Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems (K252582)Prismatik Dentalcraft, Inc.2025-11-18
DESS Dental Smart Solutions (K251547)Terrats Medical SL2025-10-31
DESS® Dental Smart Solutions (K252384)Terrats Medical SL2025-10-23
S.I.N. Dental Implant System (K252266)S.I.N. Implant System Ltda2025-10-17
Adin Customized Abutments (K250178)Adin Dental Implant Systems , Ltd.2025-10-17
Elos Accurate Hybrid Base (K251497)Elos Medtech Pinol A/S2025-10-16
Bonafix Implant Abutments (K251294)Zentek Medical, LLC2025-10-15
LOCATOR® Angled Abutment (K252944)Zest Anchors, LLC2025-10-15
SFIT Abutment (K242287)Cowellmedi Co., Ltd.2025-09-16
Customized Abutment and Screw (K242768)Chengdu Besmile Medical Technology Co., Ltd.2025-09-02
IPD Dental Implant Abutments (K251471)Implant Protesis Dental 2004, S.L.2025-08-20
LOCATOR® Angled Abutment (K250721)Zest Anchors, LLC2025-08-20
NUVENTUS NV.C™ Prosthetic Components (K251220)Infinitum Eta, Ltd.2025-07-28
ISO Abutment (K241183)Seum Medi Co., Ltd.2025-07-28
Sherlock (K250967)Open Implants, LLC2025-06-26
MIST IC (K243009)Imagine Milling Technologies, LLC2025-06-24
Geo Abutment (K242978)Geomedi Co,., Ltd.2025-06-16
Dynamic TiBase (K243530)Talladium España, SL2025-05-30
Neodent Implant System - Custom Abutments (K250614)Jjgc Indústria E Comércia DE Materiais Dentários S.A.2025-05-27
DESS Dental Smart Solutions (K250639)Terrats Medical SL2025-05-22
Preat Abutments (K243824)Preat Corporation2025-05-08
Conical Ti Base abutments (K243521)BioHorizons Implant Systems, Inc.2025-05-01
Dentsply Sirona Titanium Bases system (K250295)Dentsply Sirona2025-04-30
Medentika CAD/CAM Abutments (K242542)Medentika GmbH2025-04-22
Atlantis® Abutments in Titanium (K250081)Dentsply Sirona2025-04-11
iPhysio® System (K232383)Euroteknika2025-03-04
Custom Abutments (K243278)Institut Straumann AG2025-02-21
Straumann InLab Validated Workflow (K243478)Institut Straumann AG2025-02-19
DESS Dental Smart Solutions (K243212)Terrats Medical SL2025-02-14
Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) (K242064)Smart Denture Conversions, LLC2025-01-17
LOCATOR Angled Abutment (K243272)Zest Anchors, LLC2025-01-14
MegaGen Dental Implant Abutment (K242030)Megagen Implant Co., Ltd.2025-01-13
HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) (K241003)Hiossen, Inc.2025-01-08
NobelProcera Zirconia Implant Bridge (K240346)Nobel Biocare AB2025-01-03
IPD Dental Implant Abutments (K242819)Implant Protesis Dental 2004, S.L.2024-12-19
ALLONUS Tech Prosthetics (K241616)Allonus Tech Co., Ltd.2024-12-17
Elos Accurate® Hybrid Base™ (K242025)Elos Medtech Pinol A/S2024-12-10
LW Pre-milled Abutment (K242703)Ossvis Co., Ltd.2024-12-05
Neodent Implant System (K242686)Jjgc Indústria E Comércia DE Materiais Dentários S.A.2024-12-04
Customized Abutment (K242245)Arum Dentistry Co., Ltd.2024-11-25
Straumann® Anatomic Healing Abutments XC (AHA) (K241575)Straumann USA, LLC2024-11-11
DESS Dental Smart Solutions (K242340)Terrats Medical SL2024-11-05
Dynamic TiBase; TRI Screws (K241170)Talladium España, SL2024-10-21
PreXolid CAD/CAM abutments (K240725)Eclectic Co., Ltd.2024-10-18
TruAbutment DS; TruBase (K241485)Truabutment, Inc.2024-10-09
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment (K234142)Megagen Implant Co., Ltd.2024-09-18
Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment (K241722)Elos Medtech Pinol A/S2024-09-13
DESS Dental Smart Solutions (K240982)Terrats Medical SL2024-08-26
TDS (TECHWIN DENTAL SYSTEM) (K231932)Techwin Co., Ltd.2024-08-20
SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment (K240531)BioHorizons Implant Systems, Inc.2024-07-30
s-Clean ScanHealing Abutment (K241063)Dentis Co., Ltd.2024-07-25
BellaTek Bars (K241032)Biomet 3i, LLC2024-07-15
Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems (K240240)Prismatik Dentalcraft, Inc.2024-07-12
IPD Dental Implant Abutments (K240570)Implant Protesis Dental 2004, S.L.2024-06-07
Ti-Base & Master Fix (K240603)Arum Dentistry Co., Ltd.2024-06-05
LOCATOR Angled Abutment (Various) (K233587)Zest Anchors, LLC2024-06-03
EK Digital Abutments (K233389)Hiossen, Inc.2024-05-29
KATANA Zirconia ONE For IMPLANT (K233285)Kuraray Noritake Dental, Inc.2024-05-24
BruxZir® NOW SRC (K231940)Prismatik Dentalcraft, Inc.2024-05-15
Customized Abutment (K234112)Arum Dentistry Co., Ltd.2024-05-09
CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System (K234018)Dentsply Sirona2024-05-07
Neodent Implant System – Custom Abutments (K233857)JJGC Indústria e Comércio de Materiais Dentários S.A.2024-05-02
Protective Cap (K232528)Neobiotech Co., Ltd.2024-04-30
DESS Dental Smart Solutions (K240208)Terrats Medical SL2024-04-24
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments (K223113)Medentika GmbH2024-04-15
J & P Click Attachments (K231132)J & P Dental Technologies2024-03-26
LW Implant System – Abutment (K233167)Ossvis Co., Ltd.2024-03-25
Osteon Precision Milled Suprastructure (K233083)Implant Solutions Pty Ltd (Aka Osteon Medical)2024-03-09
DGA Abutment (K231210)Modern Dental Laboratory (Dg) Co., Ltd.2024-03-05
Zfx Abutments (K231915)Zfx GmbH - A Company of Zimvie2024-03-01
Oneday Implant Abutment (K231753)Oneday Biotech Co., Ltd.2024-02-21
TS Abutment System (K233194)Osstem Implant Co., Ltd.2024-02-20
NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium (K233208)Nobel Biocare AB2024-01-24
MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw (K233450)Megagen Implant Co., Ltd.2024-01-22
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Every clearance here is in the API, with alerts when new ones post.