Accessories, Implant, Dental, Endosseous

Device Code: 1331

Product Code(s): NDP

Device Classification Information

Device Type ID1331
Device NameAccessories, Implant, Dental, Endosseous
Regulation DescriptionEndosseous Dental Implant Accessories.
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) Exempt
CFR Regulation Number872.3980 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNDP
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1331
DeviceAccessories, Implant, Dental, Endosseous
Product CodeNDP
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEndosseous Dental Implant Accessories.
CFR Regulation Number872.3980 [🔎]
Device Problems
Fracture
168
Adverse Event Without Identified Device Or Use Problem
140
Separation Failure
134
Mechanical Problem
116
Positioning Failure
22
Driver
20
Appropriate Term/Code Not Available
16
Manufacturing, Packaging Or Shipping Problem
13
Break
12
Device-Device Incompatibility
8
Failure To Adhere Or Bond
8
Product Quality Problem
7
Device Component Or Accessory
7
Detachment Of Device Or Device Component
7
Partial Blockage
6
Improper Or Incorrect Procedure Or Method
6
Tip
6
Shaft
6
Device Handling Problem
5
Premature Separation
5
Difficult To Insert
5
Malposition Of Device
5
Defective Device
4
Separation Problem
4
Inaccurate Information
4
Material Torqued
4
Material Fragmentation
4
Device Damaged By Another Device
4
Detachment Of Device Component
4
Accessory Incompatible
4
Component Misassembled
4
Use Of Device Problem
4
Material Integrity Problem
4
Bent
4
Device Operates Differently Than Expected
3
Insufficient Information
3
Nonstandard Device
2
Difficult To Position
2
Device Markings / Labelling Problem
2
Positioning Problem
2
Sticking
2
Human Factors Issue
2
Component Or Accessory Incompatibility
2
Component Missing
2
No Apparent Adverse Event
2
Screw
1
Inadequate Instructions For Healthcare Professional
1
Device Difficult To Setup Or Prepare
1
Structural Problem
1
Activation, Positioning Or Separation Problem
1
Device Dislodged Or Dislocated
1
Physical Property Issue
1
Material Split, Cut Or Torn
1
Migration Or Expulsion Of Device
1
Difficult To Remove
1
Patient-Device Incompatibility
1
Material Discolored
1
Defective Component
1
Compatibility Problem
1
Off-Label Use
1
Incomplete Or Missing Packaging
1
Mechanical Jam
1
Component Incompatible
1
Device Contamination With Chemical Or Other Material
1
Material Deformation
1
Loose Or Intermittent Connection
1
Labelling, Instructions For Use Or Training Problem
1
Total Device Problems 816
Recalls
Manufacturer Recall Class Date Posted
1
Biomet 3i, LLC
II Jan-06-2016
2
Biomet 3i, LLC
II Dec-31-2015
3
Biomet 3i, LLC
II Nov-12-2015
4
Implant Direct Sybron Manufacturing, LLC
II Oct-09-2018
5
Implant Direct Sybron Manufacturing, LLC
II Dec-21-2017
6
Instradent USA, Inc.
II Apr-07-2017
7
Keystone Dental Inc
II Apr-19-2018
8
Nobel Biocare Usa Llc
II Jul-15-2015
9
Straumann Manufacturing, Inc.
II Jan-06-2017
10
Straumann USA, LLC
II Jan-15-2015
11
Zimmer Dental Inc
II Dec-21-2017
12
Zimmer Dental Inc
II Sep-22-2017
13
Zimmer Dental Inc
II Feb-12-2015
TPLC Last Update: 2019-04-02 19:52:08

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