FDA.reportPublic FDA data

Tapered Screw-Vent® Implant System

Primary DI
00889024014183
Brand
Tapered Screw-Vent® Implant System
Company
ZimVie US Corp LLC
Model
BAC6
Published
2015-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011028000SCREW-VENT DENTAL IMPLANT SYSTEMSulzer Dental, Inc.2001-05-21DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024014183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024014183008890240141838890240141830889024014183

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-7019zimmer.consumerrelations@zimmer.com
1-800-342-5454DentalCS@zimvie.com

Regulatory Flags#

DUNS number
119287313
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
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
08800070202999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203088ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203095ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203101ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203118ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200542Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200559Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200566Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200573Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200580Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200597Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200603Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200610Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28