CAST. NON REP. POST WITH CRCO AS-UCRCO-425

GUDID D7701245813

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

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7701245813
• NIH Device Record Key: 5589d302-849d-4d11-aa14-e38e96852346
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAST. NON REP. POST WITH CRCO
• Version Model Number: AS-UCRCO-425
• Catalog Number: AS-UCRCO-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	D7701245813 [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

[D7701245813]

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 CRCO]

• D7701254013: CAST. NON REP. POST WITH CRCO BASE,D.5.00 MM EX.2.30
• D7701245813: CAST. NON REP. POST WITH CRCO BASE,D.4.25 MM EX.2.30
• D7701067713: CAST. NON REP. POST WITH CRCO BASE, PRE-KOH D.5,00 MM
• D7701067703: CAST. NON REP. POST WITH CRCO BASE, PRE-KOH D.4.25 MM
• D7701067693: CAST. NON REP. POST WITH CRCO BASE, PRE-KOH D.3,80 MM
• D7701067683: CAST. NON REP. POST WITH CRCO BASE, PREMIUM D.3,30 MM