SURGICAL COVER SCREW SHELTA SH-VT-380

GUDID D7701064093

SURGICAL COVER SCREW SHELTA D.3.80 MM

SWEDEN & MARTINA SPA

Screw endosteal dental implant, two-piece

• Primary Device ID: D7701064093
• NIH Device Record Key: 1717ef45-50a2-490b-9660-4a7dd01f5d39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGICAL COVER SCREW SHELTA
• Version Model Number: SH-VT-380
• Catalog Number: SH-VT-380
• Company DUNS: 433815198
• Company Name: SWEDEN & MARTINA SPA
• 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: 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: 844.862.7846
• Email: info.us@sweden-martina.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7701064093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142242

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: 2015-09-21

On-Brand Devices [SURGICAL COVER SCREW SHELTA]

• D7701261393: SURGICAL COVER SCREW SHELTA D.5.00 MM
• D7701261383: SURGICAL COVER SCREW SHELTA D.4.25 MM
• D7701261373: SURGICAL COVER SCREW SHELTA D.3.80 MM
• D7701064093: SURGICAL COVER SCREW SHELTA D.3.80 MM