PiezoImplant System R2-38

GUDID D894R2380

Custom Abutment Blank TL 2.9

Rex Implants, Inc.

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: D894R2380
• NIH Device Record Key: 499ca98a-973a-4c1c-b8a2-0106e8f744ab
• Commercial Distribution Discontinuation: 2022-12-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PiezoImplant System
• Version Model Number: Custom Abutment Blank TL 2.9
• Catalog Number: R2-38
• Company DUNS: 080746478
• Company Name: Rex Implants, Inc.
• Device Count: 1
• DM Exempt: true
• 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: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D894R2380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211872

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[D894R2380]

Moist Heat or Steam Sterilization

[D894R2380]

Moist Heat or Steam Sterilization

[D894R2380]

Moist Heat or Steam Sterilization

[D894R2380]

Moist Heat or Steam Sterilization

[D894R2380]

Moist Heat or Steam Sterilization

[D894R2380]

Moist Heat or Steam Sterilization

[D894R2380]

Moist Heat or Steam Sterilization

[D894R2380]

Moist Heat or Steam Sterilization

[D894R2380]

Moist Heat or Steam Sterilization

[D894R2380]

Moist Heat or Steam Sterilization

[D894R2380]

Moist Heat or Steam Sterilization

[D894R2380]

Moist Heat or Steam Sterilization

[D894R2380]

Moist Heat or Steam Sterilization

[D894R2380]

Moist Heat or Steam Sterilization

[D894R2380]

Moist Heat or Steam Sterilization

[D894R2380]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-02-13
• Device Publish Date: 2022-12-30

On-Brand Devices [PiezoImplant System]

• D894R4530: Custom Abutment Blank BL 2.9
• D894R2380: Custom Abutment Blank TL 2.9
• D894R1380: Custom Abutment Blank TL 1.8
• D894R4030: Adapter - BL 2.9 to External Hexagon (TL 1.8) H4
• D894R4020: Adapter - BL 2.9 to External Hexagon (TL 1.8) H3
• D894R4010: Adapter - BL 2.9 to External Hexagon (TL 1.8) H2
• D894R4400: MUA Ti Base R BL 2.9
• D894R1450: MUA Angled Channel Coping Screw TL 1.8 / 2.9
• D894R1440: MUA Digital Lab Analog TL 1.8 / 2.9
• D894R1430: MUA Scan Body TL 1.8 / 2.9
• D894R1330: Digital Lab Analog TL 1.8
• D894R1320: MUA Ti Base TL 1.8 / 2.9
• D894R1290: Scan Body TL 1.8
• D894SK380: Angled Channel Driver, L (1.6 mm Hex)
• D894SK370: Angled Channel Driver, S (1.6 mm Hex)
• D894SK270: Removal Carrier BL 2.9
• D894SK200: BL MUA Driver
• D894R4660: MUA Digital Lab Analog BL 2.9
• D894R4650: MUA Angled Channel Coping Screw BL 2.9
• D894R4640: MUA Ti Base AR BL 2.9
• D894R4630: MUA Scan Body BL 2.9
• D894R4520: Digital Lab Analog BL 2.9
• D894R4490: Scan Body BL 2.9
• D894R2330: Scan Body TL 2.9