ORA Complete Attachment

GUDID 00841549113208

1 plastic ORA male Pattern, 1 gold plated closed retaining cap and 1 white block-out spacer. The ORA Implant Abutment System is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. Connection and retention may also be provided by a plastic keeper that is processed into the denture.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment

• Primary Device ID: 00841549113208
• NIH Device Record Key: 3dfd5fcd-d4a0-468d-915a-5c228ad3b8db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORA Complete Attachment
• Version Model Number: 904700
• 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
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549113208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133791

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

[00841549113208]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-08
• Device Publish Date: 2017-03-01

On-Brand Devices [ORA Complete Attachment]

• 08415491153920: 1 plastic ORA male Pattern, 1 gold plated closed retaining cap and 1 white block-out spacer. Th
• 00841549113208: 1 plastic ORA male Pattern, 1 gold plated closed retaining cap and 1 white block-out spacer. Th