Tapered Screw-Vent Implant System

GUDID 00889024021006

ZIMMER DENTAL INC.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00889024021006
• NIH Device Record Key: fb77b3a9-efb1-4853-a981-38893f2c1be6
• Commercial Distribution Discontinuation: 2016-03-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Tapered Screw-Vent Implant System
• Version Model Number: ZOCHEAL5S
• 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
• 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	00889024021006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061043

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-07
• Device Publish Date: 2015-10-23

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

• 00889024019126: TSF
• 00889024019072: TSB
• 00889024019065: TS
• 00889024016569: PSAZH4RML
• 00889024016552: PSAZH4RM
• 00889024016545: PSAZH4RFL
• 00889024016538: PSAZH4RF
• 00889024016521: PSAZH4MRM
• 00889024016514: PSAZH4M
• 00889024016507: PSAZH4L
• 00889024016491: PSAZH4
• 00889024016484: PSAZH3RML
• 00889024016477: PSAZH3RM
• 00889024016460: PSAZH3RFL
• 00889024016453: PSAZH3RF
• 00889024016446: PSAZH3MRM
• 00889024016439: PSAZH3M
• 00889024016422: PSAZH3L
• 00889024016415: PSAZH3
• 00889024016408: PSATH5RML
• 00889024016392: PSATH5RM
• 00889024016385: PSATH5RFL
• 00889024016378: PSATH5RF
• 00889024016361: PSATH5MRM
• 00889024016347: PSATH5L
• 00889024016323: PSATH4RML
• 00889024016309: PSATH4RFL
• 00889024016286: PSATH4MRM
• 00889024016262: PSATH4L
• 00889024016248: PSATH3RML
• 00889024016224: PSATH3RFL
• 00889024016200: PSATH3MRM
• 00889024016187: PSATH3L
• 00889024015050: HC445
• 00889024013766: AHS
• 00889024021020: ZOCHEAL6S
• 00889024021013: ZOCHEAL6A
• 00889024021006: ZOCHEAL5S
• 00889024020993: ZOCHEAL5A
• 00889024016590: PT341A