SURGICAL COVER SCREW SHELTA SH-VT-425-BL

GUDID D7701261383

SURGICAL COVER SCREW SHELTA D.4.25 MM

SWEDEN & MARTINA SPA

Screw endosteal dental implant, two-piece

• Primary Device ID: D7701261383
• NIH Device Record Key: 41e33060-32a3-4e6b-9009-ba4626725db5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGICAL COVER SCREW SHELTA
• Version Model Number: SH-VT-425-BL
• Catalog Number: SH-VT-425-BL
• 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	D7701261383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142242

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[D7701261383]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-30

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