FDA Registration
Active
🇪🇸 Spain
ZimVie Spain S.L.U.
Reg #: 3006411780
·
FEI: 3006411780
·
Expires 2026
Products
6
Proprietary Names
246
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- ZimVie Spain S.L.U.
- Registration Number
- 3006411780
- FEI Number
- 3006411780
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- WTC Almeda Park, Ed.4, Planta 2, C/Tirso de Molina, 40
- City
- Cornella de Llobregat Barcelona
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K132258
Owner / Operator
- Firm Name
- ZimVie US Corp LLC
- Operator Number
- 1038806
- Address
- 4555 Riverside Drive, --
- City
- Palm Beach Gardens
- State
- FL
- Postal Code
- 33410
- Country
- US
- Correspondent
- Ruth Lopez
US Agent
- Business Name
- ZimVie US Corp LLC
- Contact Name
- Henrique Nomelini Muniz
- Address
- 4555 Riverside Dr
- City
- Palm Beach Gardens
- State
- FL
- ZIP
- 33410
- Country
- US
- [email protected]
- Phone
- 561 7766700
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2017-07-11 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2017-07-11 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2002-11-26 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 1993-12-29 |
| Template | HWT | Class 1 | Orthopedic | No | 2017-03-27 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2014-11-17 |
Proprietary Names
Trabecular Metal
Zimmer ZFX
Low Profile Abutment Hexed Castable Cylinder
Low Profile Abutment Distal Extension
Low Profile One-Piece Abutment
Low Profile Abutment Non-Hexed Gold Cylinder
Low Profile Abutment Non-Hexed Temporary Cylinder
Low Profile Abutment Laser Weld Cylinder
Low Profile Abutment Titanium Retaining Screw
Low Profile Abutment Healing Cap
Low Profile Abutment Gold-Tite Retaining Screw
Low Profile Abutment Hexed Gold Cylinder
Low Profile Abutment QuickBridge
Low Profile Abutment Hexed PreFormance Temporary Cylinder
Low Profile Abutment
Certain Low Profile Abutment
Low Profile Abutment QuickBridge Replacement Cap
Low Profile Abutment Non-Hexed Castable Cylinder
Low Profile Abutment Non-Hexed PreFormance Temporary Cylinder
Certain Low Profile One-Piece Abutment
Low Profile Abutment Hexed Temporary Cylinder
Zimmer Biomet BellaTek® Abutment for Zimmer TAPERED SCREW-VENT® Implant Systems, Titanium
Zimmer® Zfx Abutment for Zimmer TAPERED SCREW-VENT® Implant Systems, Titanium
Spline Dental Imp Sys - Temp Abut
Certain PreFormance Temporary Cylinder Non-Hexed
Certain PreFormance Temporary Cylinder Hexed
NanoTite Certain PREVAIL Implant
NanoTite Certain Implant
Bellatek Abutment TSV
AdVent
BellaTek Hader Bar
BellaTek Primary Bar
BellaTek Dolder Bar
BellaTek Hybrid Bar
One-piece Implant, 3mm Angled
Conical Temporary Cylinder Hexed
Certain UCLA Gold Non-Hexed Abutment
Certain Temporary Non-Hexed Cylinder
Standard Abutment Gold Cylinder
Conical EP Healing Cap
UCLA Gold MicroMini Hexed Abutment Cylinder
Certain UCLA Gold Hexed Abutment Cylinder
Certain UCLA Gold Non-Hexed Abutment Cylinder
UCLA Gold Standard ZR Hexed Abutment Cylinder
Conical Gold Cylinder Non-Hexed
Certain GingiHue Post
IOL Gold Cylinder
Certain Temporary Hexed Cylinder
Conical Abutment Gold Standard ZR
Chamfered Gold Cylinder for Standard Abutment
Certain UCLA Gold Hexed Abutment
UCLA Gold Non-Hexed Abutment Cylinder
Conical Titanium Cylinder Non-Hexed
Temporary Cylinder
Titanium Square UniScrew
IOL Distal Extension
EP Healing Abutment
Healing Abutment
GingiHue Post
Certain Gold-Tite Hexed Screw
Conical EP Temporary Cylinder Non-Hexed
Conical Abutment
Certain UCLA Titanium Non-Hexed Abutment
Conical EP Temporary Cylinder Hexed
Temporary Cylinder with Hexed Screw
Temporary Healing Cylinder
Standard Abutment
Gold-Tite Hexed Retaining Screw
Conical Healing Cap
EP Healing Abutment
Abutment Post
UCLA Gold Hexed Abutment Cylinder
UCLA Gold Abutment Non-Hexed Cylinder
GingiHue Pre-Angled Post
Certain Conical Abutment
IOL Healing Cap
Two piece EP Healing Abutment
IOL Abutment and Screw
Certain ZiReal POST Gold-Tite Hexed Abutment Screw
Temporary Cylinder - Standard Abutment
BellaTek Encode Healing Abutment
Conical Castable Cylinder Non-Hexed
Conical Temporary Cylinder Non-Hexed
Temporary Hexed Implant Cylinder with Hexed Screw
Certain Straight Healing Abutment
Gold-Tite Hexed UniScrew
UCLA Gold Abutment Hexed Cylinder
Conical Castable Cylinder Hexed
Certain UCLA Gold Non-Hexed Cylinder
UCLA Gold Non-Hexed Abutment
Temporary Hexed Cylinder with Retention
Conical Gold Cylinder Hexed
Certain IOL Abutment
Pre-Angled Abutment
Temporary Non-Hexed Implant Cylinder with Hexed Screw
Implant Temporary Hexed Cylinder with Hex Screw
Certain EP Healing Abutment
Certain Conical Abutment Screw
Titanium Hexed UniScrew
Certain Titanium Hexed Screw
IOL Titanium Temporary Cylinder
Standard Abutment Temporary Screw
Standard Abutment Castable Plastic Cylinder
Certain BellaTek Encode Healing Abutment
Certain Provide Abutment
Temporary Non-Hexed Cylinder With Retention
UCLA Titanium Non-Hexed Abutment Cylinder
Implant Temporary Non-Hexed Cylinder with Hex Screw
Gold-Tite Square UniScrew
Certain Standard Abutment
NBR Titanium Abutment
LDA Screw NBR
NBR TIN Abutment
Eztetic
BellaTek Copymilled Bar
Certain Cover Screw
Full OSSEOTITE Certain Implant
OSSEOTITE Certain Implant
Certain MicroMini Flat Implant Cover Screw
Certain Implant Straight Cover Screw
Full OSSEOTITE XP Certain Implant
Certain Flat Implant Cover Screw
Certain Implant Headless Cover Screw
Certain Implant Cover Screw
NanoTite Tapered Certain Implant
Full OSSEOTITE Tapered Certain Implant
Certain PREVAIL Implant
OSSEOTITE Tapered Certain Implant
OSSEOTITE XP Certain Implant
Certain BellaTek Express and BellaTek Flex Abutments
Spline Dental Implant System
QuickBridge Cylinder and Cap
QuickBridge Cap
NBA Titanium Abutment
NBA TIN Abutment
LDA Screw NBA
3i T3 with DCD Non-Platform Switched Parallel Walled Implant
3i T3 Parallel Walled Implant
3i T3 Non-Platform Switched Tapered Implant
3i T3 with DCD Tapered Implant
3i T3 Tapered Implant
3i T3 with DCD Parallel Walled Implant
3i T3 with DCD Non-Platform Switched Tapered Implant
3i T3 Non-Platform Switched Parallel Walled Implant
Pre-Angled Abutments
Hex-Lock
Tapered Screw-Vent
Conical Angled Abutment
Certain Conical Angled Abutment
T3 Pro Implants
Certain BellaTek TiN Abutment
BellaTek TiN Abutment
BellaTek Titanium Abutment
Certain BellaTek Titanium Abutment
SwissPlus
Tapered SwissPlus
Zimmer Zfx NobelReplace Abutment
Zimmer 3.1mm Eztetic Implant Gold Abutment
Spline Twist
BellaTek® Patient Specific Abutment System
BELLATEK® TIN ABUTMENT
BELLATEK® TITANIUM ABUTMENT
CERTAIN® BELLATEK® TIN ABUTMENT
Immediate Molar Implants
Integral and Omnoloc Gold Copinig
CERTAIN® BELLATEK® TITANIUM ABUTMENT
BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS ENCODE ABUTMENT
Screw-Vent Endosseous Implant Abutm
TSV BellaTek Encode Healing Abutment
OSSEOTITE 2 Implant
Certain Gold-Tite Large Hexed Screw
Certain Titanium Large Hexed Screw
Prep-Tite Cap
Integral & Omniloc O-ring Attachment
BellaTek Abutment
BellaTek Certain Titanium Abutment
BellaTek Lab Designed Abutment
BellaTek Certain TiN Abutment
3i T3 Short External Hex Parallel Walled Implant
3i T3 Short External Hex Parallel Walled Implant with DCD
Standard Abutment Titanium Screw
Conical Abutment Screw
OSSEOTITE Certain PREVAIL Implant
OSSEOTITE Certain PREVAIL 2 Implant
TSX Implants
Prep-Tite Post
Certain PreFormance Post
Certain PreFormance Pre-Angled Post
Dental Accessories for Spline, Advent, SwissPlus and Tapered Screw Vent Dental Implant SystemsDental Accessories for Spl
BellaTek Encode Emergence Healing Abutments
Provisional Coping
OSSEOTITE XP Implant
LTX Implant
LTX XP Miniplant
Cover Screw Headless
Full OSSEOTITE Tapered Implant
Full OSSEOTITE Implant
Cover Screw Implant
NanoTite Tapered Implant
Implant Cover Screw
OSSEOTITE Tapered Implant
OSSEOTITE XP Miniplant
OSSEOTITE Implant
Full OSSEOTITE XP Miniplant
NanoTite Implant
Gold Hader Type Clip
Plastic Hader Type Clip
Certain LOCATOR Abutment
LOCATOR Extra Light Angle Replacement
LOCATOR Replacement Housing Kit
LOCATOR Replacement Males
LOCATOR Attachment
LOCATOR Abutment
LOCATOR Extra Light Retention Males
LOCATOR Extended Range Males
LOCATOR Light Retention Replacement Males
LOCATOR Replacement Housing
Spline Transfer Coping Screw
ZIMMER BIOMET BELLATEK ABUTMENT FOR USE WITH ZIMMER IMPLANT SYSTEMS, ZIRCONIA
ZIMMER ZFX ABUTMENT FOR USE WITH ZIMMER IMPLANT SYSTEMS, ZIRCONIA
Screw Vent Endosseus HA Coated Den
PreFormance Pre-Angled Post
PreFormance Post
PreFormance Temporary Cylinder Non-Hexed
PreFormance Temporary Cylinder Hexed
Certain Prevail Dental Implants
SBL Titanium Abutment
LDA Screw SBL
SBL TIN Abutment
One -piece Implant System
Titanium Hexed Screw
3i T3 Ex Hex Parallel Walled Implant
3i T3 with DCD Ex Hex Tapered Implant
3i T3 with DCD Ex Hex Parallel Walled Implant
3i T3 Ex Hex Tapered Implant
OSSEOTITE Certain 2 Implant
Pre-Angled Abutment Screw
Pre-Angled Abutment Washer
Dal-Ro Abutment
Dal-Ro Castable System
Dal-Ro Housing - Female Assembly
Dal-Ro Female Metal
Dal-Ro Threaded Female
Radiographic Transparency
Ti Prepable Abutment
5 Spline Dental Implant System
Establishment Types
Complaint File Establishment per 21 CFR 820.198