MILLABLE POST, REP. A-MFR-425

GUDID D7700635753

MILLABLE POST, REP. ANATOMICAL PROF., PRE-KOH 4.25

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7700635753
• NIH Device Record Key: 2d16ce79-10a3-41fc-87ef-6f9cf55fd353
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MILLABLE POST, REP.
• Version Model Number: A-MFR-425
• Catalog Number: A-MFR-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	D7700635753 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142242

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[D7700635753]

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: 2015-09-23

On-Brand Devices [MILLABLE POST, REP.]

• D7701253943: MILLABLE POST, REP. ANAT PROF, D.5.00 MM EX.2.30
• D7701253933: MILLABLE POST, REP. STRAIGHT, D.5.00 MM EX.2.30
• D7701245743: MILLABLE POST, REP. ANAT PROF, D.4.25 MM EX.2.30
• D7701245733: MILLABLE POST, REP. STRAIGHT, D.4.25 MM EX.2.30
• D7701127193: MILLABLE POST, REP. STRAIGHT PROF.,PRE-KOH 3.80MM
• D7700755503: MILLABLE POST, REP. STRAIGHT PROF.,PRE-KOH 3.80MM
• D7700635763: MILLABLE POST, REP. ANATOMICAL PROF., PRE-KOH 5.00
• D7700635753: MILLABLE POST, REP. ANATOMICAL PROF., PRE-KOH 4.25
• D7700635743: MILLABLE POST, REP. ANATOMICAL PROF., PRE-KOH 3.80
• D7700635733: MILLABLE POST, REP. ANATOMICAL PROF., PREMIUM 3.30
• D7700635723: MILLABLE POST, REP. STRAIGHT PROF.,PREMIUIM 3.30MM