Tapered Screw-Vent® Implant System

GUDID 00889024019119

ZIMMER DENTAL INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00889024019119
• NIH Device Record Key: aee90b58-9069-4007-b9cb-66e96c9f7f23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tapered Screw-Vent® Implant System
• Version Model Number: TSCW
• Company DUNS: 103167086
• Company Name: ZIMMER DENTAL INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024019119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011028

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-10-22

On-Brand Devices [Tapered Screw-Vent® Implant System]

• 00889024021556: ZRA462A
• 00889024021549: ZRA461A
• 00889024021532: ZRA452S
• 00889024021525: ZRA451S
• 00889024021518: ZRA352A
• 00889024021501: ZRA351A
• 00889024021495: ZRA342S
• 00889024021488: ZRA341S
• 00889024019140: TSI4
• 00889024019133: TSI1
• 00889024019119: TSCW
• 00889024019102: TSC5
• 00889024019096: TSC
• 00889024019089: TSB25
• 00889024018495: TACW5
• 00889024018488: TACW4
• 00889024018471: TACW3
• 00889024018464: TACW2
• 00889024018457: TACW1
• 00889024018440: TAC5
• 00889024018433: TAC4
• 00889024018426: TAC3
• 00889024018419: TAC2
• 00889024018402: TAC1
• 00889024018396: TA5C4
• 00889024018389: TA5C3
• 00889024018372: TA5C2
• 00889024018365: TA5C1
• 00889024017108: SCTS
• 00889024016293: PSATH4RF
• 00889024016231: PSATH3RM
• 00889024016217: PSATH3RF
• 00889024015661: NEA4G
• 00889024015654: NEA3G
• 00889024015258: HLA5G
• 00889024015234: HLA4G
• 00889024015197: HLA3G
• 00889024015128: HC565
• 00889024015111: HC563
• 00889024015104: HC465
• 00889024015098: HC463
• 00889024015081: HC457
• 00889024015074: HC455
• 00889024014640: DHTS2
• 00889024014633: DHTS
• 00889024014299: CAN
• 00889024014268: CAB
• 00889024014213: BACW6
• 00889024014206: BACW4
• 00889024014190: BACW2