CAST. NON REP. POST WITH GOLD AS-UCR-425

GUDID D7701245793

CAST. NON REP. POST WITH GOLD BASE,D.4.25 MM EX.2.30

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7701245793
• NIH Device Record Key: dc53618f-e5ab-4984-adce-e87f007dee9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAST. NON REP. POST WITH GOLD
• Version Model Number: AS-UCR-425
• Catalog Number: AS-UCR-425
• 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	D7701245793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161989

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[D7701245793]

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: 2018-02-15

On-Brand Devices [CAST. NON REP. POST WITH GOLD]

• D7701253993: CAST. NON REP. POST WITH GOLD BASE,D.5.00 MM EX.2.30
• D7701245793: CAST. NON REP. POST WITH GOLD BASE,D.4.25 MM EX.2.30
• D7700884253: CAST. NON REP. POST WITH GOLD BASE, PRE-KOH TG,WIDE PLATFORM
• D7700884243: CAST. NON REP. POST WITH GOLD BASE, PRE-KOH TG, MEDIUM PLAT.
• D7700884213: CAST. NON REP. POST WITH GOLD BASE, PRE-KOH TG, WIDE PLAT.
• D7700884203: CAST. NON REP. POST WITH GOLD BASE, PRE-KOH TG, MEDIUM PLAT.
• D7700872223: CAST. NON REP. POST WITH GOLD BASE, PAD ABUT.
• D7700634103: CAST. NON REP. POST WITH GOLD BASE, PREMIUM D.3.30 MM
• D7700634093: CAST. NON REP. POST WITH GOLD BASE, PRE-KOH D.3.80 MM
• D7700634083: CAST. NON REP. POST WITH GOLD BASE, PRE-KOH D.4.25 MM
• D7700634063: CAST. NON REP. POST WITH GOLD BASE, PRE-KOH D.5.00 MM