PiezoImplant System R2-38

GUDID D894R2380

Custom Abutment Blank TL 2.9

Rex Implants, Inc.

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