RP Low Margin Abutment Plastic Cylinder, 8.0 mm

GUDID 00841549111204

A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00841549111204
• NIH Device Record Key: e7b3a458-b228-4e49-a2e2-783b7eef8cba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RP Low Margin Abutment Plastic Cylinder, 8.0 mm
• Version Model Number: 904363
• 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
• 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
• 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	00841549111204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K946198

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

Moist Heat or Steam Sterilization

[00841549111204]

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