PLASTIC SLEEVE FOR UCLA

GUDID D824UCLAPLASTIC0

SURGIKOR, LLC

Basket endosteal dental implant, two-piece

• Primary Device ID: D824UCLAPLASTIC0
• NIH Device Record Key: cff3e830-0d3b-4125-ac1c-dba535744aad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLASTIC SLEEVE FOR UCLA
• Version Model Number: UCLAPLASTIC
• Company DUNS: 080321629
• Company Name: SURGIKOR, LLC
• 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: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D824UCLAPLASTIC0 [Primary]

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2019-08-21
• Device Publish Date: 2019-08-13

Devices Manufactured by SURGIKOR, LLC

• D824IRH45070 - Immediate Implant: 2024-09-24 Ø4.5mm x L7.0mm, Regular Connection, Hex Platform
• D824IWC70110 - Immediate Implant: 2022-07-28 Ø7.0mm x L11.5mm, Conical Connection, Wide Platform
• D824IWC70130 - Immediate Implant: 2022-07-28 Ø7.0mm x L13.0mm, Conical Connection, Wide Platform
• D824PIWC70112 - Immediate Implant Pack: 2022-07-27 Ø7.0mm x L11.5mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC70130 - Immediate Implant Pack: 2022-07-27 Ø7.0mm x L13.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824SK15017S0 - Titanium Base for Cad / Cam: 2020-08-04 Hex Connection, Regular Platform, Non Indexed
• D824SK15041S0 - Titanium Base for Cad / Cam: 2020-08-04 Conical Connection, Regular Platform, Non Indexed
• D824SK15042S0 - Titanium Base for Cad / Cam: 2020-08-04 Conical Connection, Wide Platform, Non Indexed