Abutment, Implant, Dental, Endosseous

Device Code: 1338

Product Code(s): NHA

Definition: To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.

Device Classification Information

Device Type ID1338
Device NameAbutment, Implant, Dental, Endosseous
Regulation DescriptionEndosseous Dental Implant Abutment.
Regulation Medical SpecialtyDental
Review PanelDental
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type510(k)
CFR Regulation Number872.3630 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNHA
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1338
DeviceAbutment, Implant, Dental, Endosseous
Product CodeNHA
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEndosseous Dental Implant Abutment.
CFR Regulation Number872.3630 [🔎]
Premarket Reviews
ManufacturerDecision
ALLIED DENTAL SOLUTIONS
 
SUBSTANTIALLY EQUIVALENT
 1
ALTATEC GMBH
 
SUBSTANTIALLY EQUIVALENT
 4
BIODENTA SWISS AG
 
SUBSTANTIALLY EQUIVALENT
 2
BIOHORIZONS IMPLANT SYSTEMS, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
BIOMET
 
SUBSTANTIALLY EQUIVALENT
 2
BIOMET 3I
 
SUBSTANTIALLY EQUIVALENT
 2
BUCKEYE MEDICAL TECHNOLOGIES LLC
 
SUBSTANTIALLY EQUIVALENT
 1
CAMLOG BIOTECHNOLOGIES AG
 
SUBSTANTIALLY EQUIVALENT
 4
CENDRES & METAUX SA
 
SUBSTANTIALLY EQUIVALENT
 1
CORTEX DENTAL IMPLANTS INDUSTRIES LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
DENTALPOINT AG
 
SUBSTANTIALLY EQUIVALENT
 1
DENTIS CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
DENTIUM CO.
 
SUBSTANTIALLY EQUIVALENT
 4
DENTIUM CO. LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
DENTIUM USA
 
SUBSTANTIALLY EQUIVALENT
 6
DENTSPLY INTERNATIONAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
DENTSPLY SIRONA
 
SUBSTANTIALLY EQUIVALENT
 2
DIGITEK DENTAL SOLUTIONS LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
DIO CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
ELOS MEDTECH PINOL A/S
 
SUBSTANTIALLY EQUIVALENT
 1
GREEN DENTECH CO LTD
 
SUBSTANTIALLY EQUIVALENT
 1
HAGER & MEISINGER GMBH
 
SUBSTANTIALLY EQUIVALENT
 2
HIOSSEN INC.
 
SUBSTANTIALLY EQUIVALENT
 2
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
 
SUBSTANTIALLY EQUIVALENT
 3
INNOBIOSURG CO.,LTD
 
SUBSTANTIALLY EQUIVALENT
 1
INSTITUT STRAUMANN AG
 
SUBSTANTIALLY EQUIVALENT
 22
IVOCLAR VIVADENT AG
 
SUBSTANTIALLY EQUIVALENT
 2
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA
 
SUBSTANTIALLY EQUIVALENT
 2
MEDENTIKA GMBH
 
SUBSTANTIALLY EQUIVALENT
 4
NEOSS LTD
 
SUBSTANTIALLY EQUIVALENT
 1
NOBEL BIOCARE
 
SUBSTANTIALLY EQUIVALENT
 13
NOBEL BIOCARE AB
 
SUBSTANTIALLY EQUIVALENT
 13
OSSTEM IMPLANT CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 2
OSSTEM IMPLANT CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 4
OSSTEM IMPLANT CO.,LTD
 
SUBSTANTIALLY EQUIVALENT
 1
OSTEOREADY LLC
 
SUBSTANTIALLY EQUIVALENT
 1
OT MEDICAL GMBH
 
SUBSTANTIALLY EQUIVALENT
 2
PREAT CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
PRISMATIK
 
SUBSTANTIALLY EQUIVALENT
 9
RODO MEDICAL, INC
 
SUBSTANTIALLY EQUIVALENT
 1
SOADCO, S.L.
 
SUBSTANTIALLY EQUIVALENT
 1
SOUTHERN IMPLANTS (PTY) LTD
 
SUBSTANTIALLY EQUIVALENT
 1
STERNGOLD DENTAL LLC
 
SUBSTANTIALLY EQUIVALENT
 2
STRAUMANN
 
SUBSTANTIALLY EQUIVALENT
 22
SWEDEN & MARTINA S.P.A.
 
SUBSTANTIALLY EQUIVALENT
 3
TALLADIUM ESPANA, SL
 
SUBSTANTIALLY EQUIVALENT
 1
THE ARGEN CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
TRUABUTMENT INC.
 
SUBSTANTIALLY EQUIVALENT
 2
ZEST ANCHORS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ZEST ANCHORS,LLC ALSO DBA ZEST ANCHORS,INC. AND ZEST ANCHORS
 
SUBSTANTIALLY EQUIVALENT
 1
ZIMMER, INC.
 
SUBSTANTIALLY EQUIVALENT
 5
Device Problems
Fracture
 772
Mechanical Problem
 207
Migration Or Expulsion Of Device
137
Failure To Osseointegrate
 136
Screw
 87
Positioning Problem
 46
Failure To Advance
 45
Separation Failure
39
No Apparent Adverse Event
 36
Unintended Movement
 34
Break
 21
Positioning Failure
19
Manufacturing, Packaging Or Shipping Problem
 14
Adverse Event Without Identified Device Or Use Problem
 11
Difficult To Remove
10
Insufficient Information
 10
Device Damaged By Another Device
 7
Unsealed Device Packaging
 6
Loss Of Osseointegration
 5
Detachment Of Device Or Device Component
 5
Naturally Worn
 4
Loose Or Intermittent Connection
 4
Use Of Device Problem
 4
Device Component Or Accessory
 3
Product Quality Problem
 3
Device Issue
 3
Device Handling Problem
 2
Loosening Of Implant Not Related To Bone-Ingrowth
 2
Inadequacy Of Device Shape And/or Size
 2
Entrapment Of Device
 2
Defective Device
 2
Nonstandard Device
 2
Improper Or Incorrect Procedure Or Method
 2
Loss Of Or Failure To Bond
 2
Device Dislodged Or Dislocated
 2
Contamination / Decontamination Problem
2
Delivered As Unsterile Product
 1
Appropriate Term/Code Not Available
 1
Component Missing
1
Failure To Adhere Or Bond
 1
Unexpected Therapeutic Results
1
Device Inoperable
 1
Data Problem
 1
Device Operates Differently Than Expected
 1
Device Slipped
 1
Difficult To Insert
 1
Malposition Of Device
1
Detachment Of Device Component
 1
Device Contamination With Chemical Or Other Material
 1
Application Program Problem
 1
Component Incompatible
 1
Material Separation
 1
Total Device Problems 1704
Recalls
Manufacturer Recall Class Date Posted
1
Biomet 3i, LLC
 II Dec-20-2016
2
Biomet 3i, LLC
 II Aug-12-2016
3
Biomet 3i, LLC
 II Sep-11-2015
4
Biomet 3i, LLC
 II Sep-05-2014
5
Biomet 3i, LLC
 II Mar-17-2014
6
Implant Direct Sybron Manufacturing, LLC
 II Mar-22-2018
7
Implant Direct Sybron Manufacturing, LLC
 II Feb-06-2018
8
Implant Direct Sybron Manufacturing, LLC
 II Oct-03-2017
9
Implant Direct Sybron Manufacturing, LLC
 II Dec-08-2015
10
Keystone Dental Inc
 II Feb-14-2018
11
Nobel Biocare Usa Llc
 II Jul-23-2018
12
Southern Implants, (Pty.) Ltd.
 II Apr-16-2018
TPLC Last Update: 2019-04-02 19:52:16
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