PUR Waxing Sleeve RP Non-Engaging

GUDID 08415491155788

PUR Waxing Sleeve RP Non-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: 08415491155788
• NIH Device Record Key: d1713762-30eb-4952-bec6-6ff7b0e142c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PUR Waxing Sleeve RP Non-Engaging
• Version Model Number: 904784
• 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	08415491155788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151928

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08415491155788]

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: 2017-03-06

On-Brand Devices [PUR Waxing Sleeve RP Non-Engaging]

• 08415491155788: PUR Waxing Sleeve RP Non-Engaging. This product is designed to fit over the titanium post and c
• 00841549113628: PUR Waxing Sleeve RP Non-Engaging. This product is designed to fit over the titanium post and c