| Device Type ID | 1331 |
| Device Name | Accessories, Implant, Dental, Endosseous |
| Regulation Description | Endosseous Dental Implant Accessories. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 872.3980 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NDP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1331 |
| Device | Accessories, Implant, Dental, Endosseous |
| Product Code | NDP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Endosseous Dental Implant Accessories. |
| CFR Regulation Number | 872.3980 [🔎] |
| 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 |