LOCATOR EXTRA LIGHT RETENTION 8548

GUDID 00893202000424

LOCATOR EXTRA LIGHT RETENTION EXTEND.RANGE MALE, RED (4 PCS)

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00893202000424
• NIH Device Record Key: 052c46c5-0b97-4785-97a4-3309a02c0558
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOCATOR EXTRA LIGHT RETENTION
• Version Model Number: 8548
• Catalog Number: 8548
• 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
GS1	00893202000424 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142242

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00893202000424]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-08-05

On-Brand Devices [LOCATOR EXTRA LIGHT RETENTION]

• 00893202000424: LOCATOR EXTRA LIGHT RETENTION EXTEND.RANGE MALE, RED (4 PCS)
• 00893202000363: LOCATOR EXTRA LIGHT RETENTION MALE, BLUE (4 PCS)