15GR ANGLE PRE-MADE POST, REP. AS-MAR15-500

GUDID D7701253923

15GR ANGLE PRE-MADE POST, REP. ANAT. PROF.,D.5.00 MM EX.2.30

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7701253923
• NIH Device Record Key: f99660e2-10f6-4835-88a8-b430e81f0e82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 15GR ANGLE PRE-MADE POST, REP.
• Version Model Number: AS-MAR15-500
• Catalog Number: AS-MAR15-500
• 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	D7701253923 [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

[D7701253923]

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 [15GR ANGLE PRE-MADE POST, REP.]

• D7701253923: 15GR ANGLE PRE-MADE POST, REP. ANAT. PROF.,D.5.00 MM EX.2.30
• D7701245713: 15GR ANGLE PRE-MADE POST, REP. ANAT. PROF.,D.4.25 MM EX.2.30
• D7700875783: 15GR ANGLE PRE-MADE POST, REP. H6 MM, PRE-KOH TG, WIDE PLAT.
• D7700875773: 15GR ANGLE PRE-MADE POST, REP. H6 MM, PRE-KOH TG,MEDIUM PLAT.
• D7700636033: 15GR ANGLE PRE-MADE POST, REP. ANAT. PROF., PRE-KOH D.5.00 MM
• D7700636023: 15GR ANGLE PRE-MADE POST, REP. ANAT. PROF., PRE-KOH D.4.25 MM
• D7700636013: 15GR ANGLE PRE-MADE POST, REP. ANAT. PROF., PRE-KOH D.3.80 MM
• D7700635993: 15GR ANGLE PRE-MADE POST, REP. STRAIGHT PROF., PREMIUM D.3.30