LOCATOR Fixed

GUDID 10840481132572

LOCATOR FIXED Insert, Anterior/Posterior (Tan), 10 pieces

Zest Anchors, LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10840481132572
• NIH Device Record Key: a3eb0f51-e97a-4e6a-b756-2f36af7f2a65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOCATOR Fixed
• Version Model Number: 09506-10
• Company DUNS: 078387192
• Company Name: Zest Anchors, LLC
• Device Count: 10
• 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: true
• Expiration Date: false
• 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(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com
• Phone: +1(877)649-0084
• Email: quality@zestdent.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840481132575 [Primary]
GS1	10840481132572 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213391

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-15
• Device Publish Date: 2023-09-07

On-Brand Devices [LOCATOR Fixed]

• 00840481134623: LOCATOR FIXED Lab Package
• 00840481134616: LOCATOR FIXED Tooling Package
• 00840481134470: LOCATOR FIXED Silver Starter Kit
• 00840481133619: LOCATOR FIXED Optional Removal Tip
• 00840481132681: LOCATOR FIXED Seating and Removal Tool
• 00840481132674: LOCATOR FIXED Core Tool Handle
• 00840481132667: LOCATOR Fixed Processing Package, Mid Arch (Blue)
• 00840481132650: LOCATOR Fixed Processing Package, Anterior/Posterior (Tan)
• 00840481132643: LOCATOR Fixed Processing Package, Four Unit (Green)
• 10840481132633: LOCATOR FIXED Denture Attachment Housing, 10 pieces
• 10840481132626: LOCATOR FIXED Denture Attachment Housing (4 pack)
• 00840481132612: LOCATOR FIXED Denture Attachment Housing
• 10840481132602: LOCATOR FIXED Insert, Mid Arch (Blue), 10 pieces
• 10840481132596: LOCATOR FIXED Insert, Mid Arch (Blue) (2 pack)
• 10840481132572: LOCATOR FIXED Insert, Anterior/Posterior (Tan), 10 pieces
• 10840481132565: LOCATOR FIXED Insert, Anterior/Posterior (Tan) (2 pack)
• 10840481132541: LOCATOR FIXED Insert, Four Unit (Green), 10 pieces
• 00840481122156: LOCATOR FIXED Bronze Starter Kit
• 00840481109782: LOCATOR FIXED Gold Starter Kit
• 10840481132534: LOCATOR FIXED Insert, Four Unit (Green), 10 pieces
• 00840481134579: LOCATOR FIXED Starter Processing Component Storage Kit
• 00840481135330: LOCATOR FIXED Bronze Starter Kit, PDS