N/A

GUDID 00889024021280

ZIMMER DENTAL INC.

Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece

• Primary Device ID: 00889024021280
• NIH Device Record Key: cfd22c97-96a3-47ee-b3b9-9cc9f49bdb5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: ZOP30A13
• Company DUNS: 103167086
• Company Name: ZIMMER DENTAL INC.
• Device Count: 1
• DM Exempt: false
• 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	00889024021280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052997

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-09

On-Brand Devices [N/A]

• 00889024015067: HC453
• 00889024011038: 0602
• 00889024017146: SP1203
• 00889024011496: 1203
• 00889024021327: ZOP30S13
• 00889024021310: ZOP30S11
• 00889024021303: ZOP30S10
• 00889024021280: ZOP30A13
• 00889024021273: ZOP30A11
• 00889024021266: ZOP30A10
• 00889024017139: SP0201DSN
• 00889024015630: MTL