FDA.reportPublic FDA data

Zimmer ZFX Component

Primary DI
00889024014510
Brand
Zimmer ZFX Component
Company
ZimVie US Corp LLC
Model
CROWNPMMA
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080182000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080182000ZENO PMMA DISCWieland Dental + Technik GmbH & Co. KG2008-04-08EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024014510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024014510008890240145108890240145100889024014510

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-7019zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
119287313
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844868052463T3® ProDEPTHGTRAYN/A2026-05-28
00844868052470T3® PROEXHEXTOOLTRAY2026-05-28
00844868052487T3® PROOPENWRENCHTRAYN/A2026-05-28
00844868052494T3® PROT3PDRILLTRAYN/A2026-05-28
00844868052500T3® PROT3PLIDBASE2026-05-28
00844868052517T3® PROT3PTAPTRAY342026-05-28
00844868052524T3® PROT3PTAPTRAY56N/A2026-05-28
00844868052531T3® PROT3PTOOLTRAYN/A2026-05-28
00844868052548T3® ShortT3SHORTTRAYN/A2026-05-28
00844868052814Terrats Competitive Connection AbutmentsMALDAGU2026-05-18
00844868052821Terrats Competitive Connection AbutmentsNALDAG352026-05-18
00844868052838Terrats Competitive Connection AbutmentsNBLDAG512026-05-18
00844868052845Terrats Competitive Connection AbutmentsTXLDAT32026-05-18
00844868052852Terrats Competitive Connection AbutmentsNRLDAG432026-05-18
00844868052890Terrats Competitive Connection AbutmentsMSLDAG372026-05-18
00844868052906Terrats Competitive Connection AbutmentsMSLDAT452026-05-18
00844868052913Terrats Competitive Connection AbutmentsNALDAG432026-05-18
00844868052937Terrats Competitive Connection AbutmentsNRLDAG502026-05-18
00844868052951Terrats Competitive Connection AbutmentsNBLDAG352026-05-18
00844868052968Terrats Competitive Connection AbutmentsSTLDAT652026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EPOLPMFLAG5600PMMA CAD/CAM discPOLIDENT d.o.o.EBG2025-05-13
EPOLPMMA1270PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1350PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1430PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA0230PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0310PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0390PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0470PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0550PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0630PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0710PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0790PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0870PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0950PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0070PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1030PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1110PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1190PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLKML200160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML200200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02