ERA Implant Abutment Std Ang Base, 3mm Cuff (AE)

GUDID 00841549113895

ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00841549113895
• NIH Device Record Key: ab469be3-28f1-49b0-9378-a1bc611af574
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERA Implant Abutment Std Ang Base, 3mm Cuff (AE)
• Version Model Number: 904821
• 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: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549113895 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914764

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00841549113895]

Moist Heat or Steam Sterilization

[00841549113895]

Moist Heat or Steam Sterilization

[00841549113895]

Moist Heat or Steam Sterilization

[00841549113895]

Moist Heat or Steam Sterilization

[00841549113895]

Moist Heat or Steam Sterilization

[00841549113895]

Moist Heat or Steam Sterilization

[00841549113895]

Moist Heat or Steam Sterilization

[00841549113895]

Moist Heat or Steam Sterilization

[00841549113895]

Moist Heat or Steam Sterilization

[00841549113895]

Moist Heat or Steam Sterilization

[00841549113895]

Moist Heat or Steam Sterilization

[00841549113895]

Moist Heat or Steam Sterilization

[00841549113895]

Moist Heat or Steam Sterilization

[00841549113895]

Moist Heat or Steam Sterilization

[00841549113895]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-08
• Device Publish Date: 2020-05-29

Devices Manufactured by STERNGOLD DENTAL LLC

• 00841549119187 - Stern Snap One Piece Abutment 1mm Cuff (BK): 2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
• 00841549119194 - Stern Snap One Piece Abutment 2mm Cuff (BK): 2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
• 00841549119200 - Stern Snap One Piece Abutment 3mm Cuff (BK): 2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
• 00841549119217 - Stern Snap One Piece Abutment 4mm Cuff (BK): 2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
• 00841549119224 - Stern Snap One Piece Abutment 5mm Cuff (BK): 2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
• 00841549119231 - Stern Snap Abutment Base 2.4mm (BK): 2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota
• 00841549119248 - Stern Snap Abutment Base 3.0mm (BK): 2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota
• 00841549119255 - Stern Snap Abutment Base 4.0mm (BK): 2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota