TRU Waxing Sleeve NP Engaging

GUDID 08415491154552

TRU Waxing Sleeve NP Engaging. This product is designed to fit over the titanium post and core and can easily be modified, shaped, and waxed-to to create an ideal metal support for a fixed prosthesis.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491154552
• NIH Device Record Key: 10a80ddc-7d8f-476e-a729-f5efc269f403
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRU Waxing Sleeve NP Engaging
• Version Model Number: 904032
• Company DUNS: 124763728
• Company Name: STERNGOLD DENTAL LLC
• 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: false
• 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: 401-871-3489
• Email: maria.rao@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08415491154552 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150968

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08415491154552]

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: 2017-03-02

On-Brand Devices [TRU Waxing Sleeve NP Engaging]

• 08415491154552: TRU Waxing Sleeve NP Engaging. This product is designed to fit over the titanium post and core
• 00841549110269: TRU Waxing Sleeve NP Engaging. This product is designed to fit over the titanium post and core