PRE-MADE REP. POST ANATOMICAL A-MDR-380-1

GUDID D7700636273

PRE-MADE REP. POST ANATOMICAL PROF., H1 MM, PRE-KOH D.3.80MM

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7700636273
• NIH Device Record Key: c3aced9b-aa87-4467-8b4e-53df9cd3d8ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRE-MADE REP. POST ANATOMICAL
• Version Model Number: A-MDR-380-1
• Catalog Number: A-MDR-380-1
• 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	D7700636273 [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

[D7700636273]

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 [PRE-MADE REP. POST ANATOMICAL]

• D7701253913: PRE-MADE REP. POST ANATOMICAL PROF., H4 MM,D.5.00MM EX.2.30
• D7701253903: PRE-MADE REP. POST ANATOMICAL PROF., H2 MM,D.5.00MM EX.2.30
• D7701253893: PRE-MADE REP. POST ANATOMICAL PROF., H1 MM,D.5.00MM EX.2.30
• D7701245703: PRE-MADE REP. POST ANATOMICAL PROF., H4 MM,D.4.25MM EX.2.30
• D7701245693: PRE-MADE REP. POST ANATOMICAL PROF., H2 MM,D.4.25MM EX.2.30
• D7701245683: PRE-MADE REP. POST ANATOMICAL PROF., H1 MM,D.4.25MM EX.2.30
• D7700636353: PRE-MADE REP. POST ANATOMICAL PROF., H4 MM, PRE-KOH D.5.00MM
• D7700636343: PRE-MADE REP. POST ANATOMICAL PROF., H2 MM, PRE-KOH D.5.00MM
• D7700636333: PRE-MADE REP. POST ANATOMICAL PROF., H1 MM, PRE-KOH D.5.00MM
• D7700636323: PRE-MADE REP. POST ANATOMICAL PROF., H4 MM, PRE-KOH D.4.25MM
• D7700636313: PRE-MADE REP. POST ANATOMICAL PROF., H2 MM, PRE-KOH D.4.25MM
• D7700636303: PRE-MADE REP. POST ANATOMICAL PROF., H1 MM, PRE-KOH D.4.25MM
• D7700636293: PRE-MADE REP. POST ANATOMICAL PROF., H4 MM, PRE-KOH D.3.80MM
• D7700636283: PRE-MADE REP. POST ANATOMICAL PROF., H2 MM, PRE-KOH D.3.80MM
• D7700636273: PRE-MADE REP. POST ANATOMICAL PROF., H1 MM, PRE-KOH D.3.80MM
• D7700636263: PRE-MADE REP. POST ANATOMICAL PROF., H4 MM, PREMIUM D.3.30MM
• D7700636253: PRE-MADE REP. POST ANATOMICAL PROF., H2 MM, PREMIUM D.3.30MM
• D7700636243: PRE-MADE REP. POST ANATOMICAL PROF., H1 MM, PREMIUM D.3.30MM