STRAIGHT PRE-MADE ABUTMENT A-MD-TS-EX230-1

GUDID D7701096013

STRAIGHT PRE-MADE ABUTMENT H1 HEX 2,30 MM, PRE-KOH

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7701096013
• NIH Device Record Key: 363f581e-aa94-4862-905c-86930c8632c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STRAIGHT PRE-MADE ABUTMENT
• Version Model Number: A-MD-TS-EX230-1
• Catalog Number: A-MD-TS-EX230-1
• 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	D7701096013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162028

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[D7701096013]

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: 2017-03-28

On-Brand Devices [STRAIGHT PRE-MADE ABUTMENT]

• D7701107053: STRAIGHT PRE-MADE ABUTMENT H3 HEX 2,50 MM, PRE-KOH
• D7701107023: STRAIGHT PRE-MADE ABUTMENT H3 HEX 2,30 MM, PRE-KOH
• D7701096083: STRAIGHT PRE-MADE ABUTMENT H5 HEX 2,50 MM, PRE-KOH
• D7701096073: STRAIGHT PRE-MADE ABUTMENT H2 HEX 2,50 MM, PRE-KOH
• D7701096063: STRAIGHT PRE-MADE ABUTMENT H1 HEX 2,50 MM, PRE-KOH
• D7701096053: STRAIGHT PRE-MADE ABUTMENT H0,5 HEX 2,50 MM, PRE-KOH
• D7701096033: STRAIGHT PRE-MADE ABUTMENT H5 HEX 2,30 MM, PRE-KOH
• D7701096023: STRAIGHT PRE-MADE ABUTMENT H2 HEX 2,30 MM, PRE-KOH
• D7701096013: STRAIGHT PRE-MADE ABUTMENT H1 HEX 2,30 MM, PRE-KOH
• D7701096003: STRAIGHT PRE-MADE ABUTMENT H0,5 HEX 2,30 MM, PRE-KOH
• D7701441183: STRAIGHT PRE-MADE ABUTMENT D.3.80, H.3 MM
• D7701441173: STRAIGHT PRE-MADE ABUTMENT D.3.80, H.2 MM
• D7701441163: STRAIGHT PRE-MADE ABUTMENT D.3.80, H.1 MM
• D7701441153: STRAIGHT PRE-MADE ABUTMENT D.3.30, H.3 MM
• D7701441143: STRAIGHT PRE-MADE ABUTMENT D.3.30, H.2 MM
• D7701441133: STRAIGHT PRE-MADE ABUTMENT D.3.30, H.1 MM
• D7701441123: STRAIGHT PRE-MADE ABUTMENT D.3.30, H.0,5 MM
• D7701605183: STRAIGHT PRE-MADE ABUTMENT D.3,80, H.15MM, REPOSITIONABLE
• D7701605173: STRAIGHT PRE-MADE ABUTMENT D.3,30, H.15MM, REPOSITIONABLE