SIMPLE TEMP. POST PEEK+TIT REP AS-MPSCR-425

GUDID D7701245623

SIMPLE TEMP. POST PEEK+TIT REP ANAT. PROF.,D.4.25MM EX.2.30

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7701245623
• NIH Device Record Key: 99bd7e39-c51c-4d6e-a4bc-2c69be231e55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIMPLE TEMP. POST PEEK+TIT REP
• Version Model Number: AS-MPSCR-425
• Catalog Number: AS-MPSCR-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	D7701245623 [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

[D7701245623]

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 [SIMPLE TEMP. POST PEEK+TIT REP]

• D7701253833: SIMPLE TEMP. POST PEEK+TIT REP ANAT. PROF.,D.5.00MM EX.2.30
• D7701245623: SIMPLE TEMP. POST PEEK+TIT REP ANAT. PROF.,D.4.25MM EX.2.30
• D7700879423: SIMPLE TEMP. POST PEEK+TIT REP ANAT. PROF., PREMIUM D.5.00MM
• D7700879413: SIMPLE TEMP. POST PEEK+TIT REP ANAT. PROF., PREMIUM D.4.25MM
• D7700879403: SIMPLE TEMP. POST PEEK+TIT REP ANAT. PROF., PREMIUM D.3.80MM
• D7700879393: SIMPLE TEMP. POST PEEK+TIT REP ANAT. PROF., PREMIUM D.3.30MM
• D7700879383: SIMPLE TEMP. POST PEEK+TIT REP STRAIGHT PROF., PREMIUM 3.30MM