BALL ATTACHMENT ACCESSORIES

GUDID 07290113352186

Silicon Cap Clear

DENTIN IMPLANTS TECHNOLOGIES LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07290113352186
• NIH Device Record Key: 5ede4cb3-96b9-4183-8d0c-bdd827f9c17f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BALL ATTACHMENT ACCESSORIES
• Version Model Number: SCO-6001
• Company DUNS: 600215680
• Company Name: DENTIN IMPLANTS TECHNOLOGIES LTD
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290113352186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120530

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-09-10

On-Brand Devices [BALL ATTACHMENT ACCESSORIES]

• 07290113355194: Ball Insert Peek
• 07290113353145: Ball Insert Silicon
• 07290113353138: Ball Housing Minor
• 07290113352216: Metal Cap
• 07290113352209: Silicon Cap Extra Soft
• 07290113352193: Silicon Cap Soft
• 07290113352186: Silicon Cap Clear