SIMPLE TEMP. POST TIT. NON REP AS-MPSCI-425

GUDID D7701245643

SIMPLE TEMP. POST TIT. NON REP STRAIGHT PROF.,D.4.25 EX.2.30

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7701245643
• NIH Device Record Key: 6a5afcee-5de8-4af3-9862-666df7c489a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIMPLE TEMP. POST TIT. NON REP
• Version Model Number: AS-MPSCI-425
• Catalog Number: AS-MPSCI-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	D7701245643 [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

[D7701245643]

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 TIT. NON REP]

• D7701253853: SIMPLE TEMP. POST TIT. NON REP STRAIGHT PROF.,D.5.00 EX.2.30
• D7701245643: SIMPLE TEMP. POST TIT. NON REP STRAIGHT PROF.,D.4.25 EX.2.30
• D7701126793: SIMPLE TEMP. POST TIT. NON REP STRAIGHT PROF., PRE/KOH D.5.00
• D7701126783: SIMPLE TEMP. POST TIT. NON REP STRAIGHT PROF., PRE/KOH D.4.25
• D7701126773: SIMPLE TEMP. POST TIT. NON REP STRAIGHT PROF., PRE/KOH D.3.80
• D7701120873: SIMPLE TEMP. POST TIT. NON REP STRAIGHT PROF., PREMIUM D.3.30
• D7700879273: SIMPLE TEMP. POST TIT. NON REP ANAT.PROF., PRE-KOH D.5.00MM
• D7700879263: SIMPLE TEMP. POST TIT. NON REP ANAT.PROF., PRE-KOH D.4.25MM
• D7700879253: SIMPLE TEMP. POST TIT. NON REP ANAT.PROF., PRE-KOH D.3.80MM
• D7700879243: SIMPLE TEMP. POST TIT. NON REP ANAT.PROF., PREMIUM D.3.30MM
• D7700635713: SIMPLE TEMP. POST TIT. NON REP WIDE PROF., PRE-KOH D.5.00MM
• D7700635703: SIMPLE TEMP. POST TIT. NON REP WIDE PROF., PRE-KOH D.4.25MM
• D7700635693: SIMPLE TEMP. POST TIT. NON REP WIDE PROF., PRE-KOH D.3.80MM
• D7700635683: SIMPLE TEMP. POST TIT. NON REP WIDE PROF., PREMIUM D.3.30MM