PLAIN ABUTMENT H3 MM AS-PLAIN-ABU500-3

GUDID D7701254133

PLAIN ABUTMENT H3 MM D.5.00 MM EX.2.30

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7701254133
• NIH Device Record Key: ec885d3b-f755-4057-b19d-2a271173b192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLAIN ABUTMENT H3 MM
• Version Model Number: AS-PLAIN-ABU500-3
• Catalog Number: AS-PLAIN-ABU500-3
• 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	D7701254133 [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

[D7701254133]

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: 2018-02-14

On-Brand Devices [PLAIN ABUTMENT H3 MM]

• D7701254133: PLAIN ABUTMENT H3 MM D.5.00 MM EX.2.30
• D7701245933: PLAIN ABUTMENT H3 MM D.4.25 MM EX.2.30
• D7701029783: PLAIN ABUTMENT H3 MM PREMIUM D.5.00 MM
• D7701029753: PLAIN ABUTMENT H3 MM PREMIUM D.4.25 MM
• D7701029723: PLAIN ABUTMENT H3 MM PREMIUM D.3.80 MM
• D7701029693: PLAIN ABUTMENT H3 MM PREMIUM D.3.30 MM
• D7702472443: PLAIN ABUTMENT H3 MM D.5.00C HEX.2.30
• D7702472383: PLAIN ABUTMENT H4 MM D.4.25C HEX.2.30
• D7702472333: PLAIN ABUTMENT H3 MM D.4.25C HEX.2.30
• D7702472183: PLAIN ABUTMENT H3 MM D.3.80C HEX.2.30