Ball Abutment BAB4010

GUDID D755BAB40100

Endosseous dental implant abutment

DENTIUM USA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D755BAB40100
• NIH Device Record Key: 7981d2ee-3ba8-4745-bff2-3cbd5e840b71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ball Abutment
• Version Model Number: BAB4010
• Catalog Number: BAB4010
• Company DUNS: 079689366
• Company Name: DENTIUM USA
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: +1(714)226-0229
• Email: cs@dentiumusa.com

Device Dimensions

• Length: 11.1 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D755BAB40100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052957

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[D755BAB40100]

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: 2016-08-29

On-Brand Devices [Ball Abutment]

• D755BAB40400: Endosseous dental implant abutment
• D755BAB40300: Endosseous dental implant abutment
• D755BAB40200: Endosseous dental implant abutment
• D755BAB40100: Endosseous dental implant abutment