| Proprietary Name: |
Abutment Post; BellaTek Encode Healing Abutment; Certain BellaTek Encode Healing Abutment; Certain Conical Abutment; Certain Conical Abutment Screw; Certain EP Healing Abutment; Certain GingiHue Post; Certain Gold-Tite Hexed Screw; Certain IOL Abutment; Certain Provide Abutment; Certain Standard Abutment; Certain Straight Healing Abutment; Certain Temporary Hexed Cylinder; Certain Temporary Non-Hexed Cylinder; Certain Titanium Hexed Screw; Certain UCLA Gold Hexed Abutment; Certain UCLA Gold Hexed Abutment Cylinder; Certain UCLA Gold Non-Hexed Abutment; Certain UCLA Gold Non-Hexed Abutment Cylinder; Certain UCLA Gold Non-Hexed Cylinder; Certain UCLA Titanium Non-Hexed Abutment; Certain ZiReal POST Gold-Tite Hexed Abutment Screw; Chamfered Gold Cylinder for Standard Abutment; Conical Abutment; Conical Abutment Gold Standard ZR; Conical Castable Cylinder Hexed; Conical Castable Cylinder Non-Hexed; Conical EP Healing Cap; Conical EP Temporary Cylinder Hexed; Conical EP Temporary Cylinder Non-Hexed; Conical Gold Cylinder Hexed; Conical Gold Cylinder Non-Hexed; Conical Healing Cap; Conical Temporary Cylinder Hexed; Conical Temporary Cylinder Non-Hexed; Conical Titanium Cylinder Non-Hexed; EP Healing Abutment; EP Healing Abutment; GingiHue Post; GingiHue Pre-Angled Post; Gold-Tite Hexed Retaining Screw; Gold-Tite Hexed UniScrew; Gold-Tite Square UniScrew; Healing Abutment; Implant Temporary Hexed Cylinder with Hex Screw; Implant Temporary Non-Hexed Cylinder with Hex Screw; IOL Abutment and Screw; IOL Distal Extension; IOL Gold Cylinder; IOL Healing Cap; IOL Titanium Temporary Cylinder; Pre-Angled Abutment; Standard Abutment; Standard Abutment Castable Plastic Cylinder; Standard Abutment Gold Cylinder; Standard Abutment Temporary Screw; Temporary Cylinder; Temporary Cylinder - Standard Abutment; Temporary Cylinder with Hexed Screw; Temporary Healing Cylinder; Temporary Hexed Cylinder with Retention; Temporary Hexed Implant Cylinder with Hexed Screw; Temporary Non-Hexed Cylinder With Retention; Temporary Non-Hexed Implant Cylinder with Hexed Screw; Titanium Hexed UniScrew; Titanium Square UniScrew; Two piece EP Healing Abutment; UCLA Gold Abutment Hexed Cylinder; UCLA Gold Abutment Non-Hexed Cylinder; UCLA Gold Hexed Abutment Cylinder; UCLA Gold MicroMini Hexed Abutment Cylinder; UCLA Gold Non-Hexed Abutment; UCLA Gold Non-Hexed Abutment Cylinder; UCLA Gold Standard ZR Hexed Abutment Cylinder; UCLA Titanium Non-Hexed Abutment Cylinder |
| Classification Name: |
ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS |
| Product Code: |
NHA |
| Device Class: |
2 |
| Regulation Number: |
872.3630 |
| Medical Specialty: |
Dental |
| Registered Establishment Name: |
ZimVie Spain S.L.U.
|
| Registered Establishment Number: |
3006411780
|
| Premarket Submission Number: |
K072642 |
| Owner/Operator: |
ZimVie US Corp LLC |
| Owner/Operator Number: |
1038806
|
| Establishment Operations: |
Complaint File Establishment
|
