ERA® DO SP Master Kit w/ Tools SS

GUDID 00841549101748

This part contains: Five small post females, (2- 0° , 1 each 5°, 11°, and 17°), Males, 5 sets of 5, (two each of white and black and one orange), 2 metal jackets, 2 Processing jigs, 2 alignment handles, 1 of each Gutta percha drill, pilot drill, countersink bur, core cutter bur and seating tool. These attachments are placed in the retained tooth root, which has been prepared to receive the fixed attachment component. The other component of the attachment becomes part of a patient removable overdenture, which is a denture partially supported by one or more retained roots. ERA Direct Placement Overdenture is available in standard and micro sizes. An optional metal jacket is also available to hold the attachment male in the denture base and is sold pre-loaded with a black fabrication male. Intended to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function.

STERNGOLD DENTAL LLC

Resilient dental precision attachment

• Primary Device ID: 00841549101748
• NIH Device Record Key: 6f27c393-4585-41be-abf1-24b7915e535f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERA® DO SP Master Kit w/ Tools SS
• Version Model Number: 811400
• 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: true
• 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: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549101748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913348

FDA Product Code

• EGG: Attachment, Precision, All

Sterilization

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

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[00841549101748]

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[00841549101748]

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[00841549101748]

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[00841549101748]

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-15
• Device Publish Date: 2020-07-07

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