PiezoImplant System B2-095C

GUDID D894B2095C0

REX BL 2.9 x 5 H9 packaged with Cover Screw BL 2.9

Rex Implants, Inc.

Dental implant system

• Primary Device ID: D894B2095C0
• NIH Device Record Key: 4223f5ab-bb9f-4c3a-85aa-06b124e68a5f
• Commercial Distribution Discontinuation: 2025-11-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PiezoImplant System
• Version Model Number: REX BL 2.9 x 5 H9
• Catalog Number: B2-095C
• Company DUNS: 080746478
• Company Name: Rex Implants, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Dimensions

• Height: 9 Millimeter
• Width: 5 Millimeter
• Height: 9 Millimeter
• Width: 5 Millimeter
• Height: 9 Millimeter
• Width: 5 Millimeter
• Height: 9 Millimeter
• Width: 5 Millimeter
• Height: 9 Millimeter
• Width: 5 Millimeter
• Height: 9 Millimeter
• Width: 5 Millimeter
• Height: 9 Millimeter
• Width: 5 Millimeter
• Height: 9 Millimeter
• Width: 5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D894B2095C0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211872

FDA Product Code

• NRQ: Blade-Form Endosseous Dental Implant

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-03-12
• Device Publish Date: 2022-12-24

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
• D894R4110: Impression Coping BL 2.9 - Closed Tray
• D894R4670: Impression Coping BL 2.9 - Open Tray
• D894R4480: Angled Abutment BL 2.9 (15°)
• D894R4450: Provisional Cylinder R BL 2.9
• D894R4440: Provisional Cylinder AR BL 2.9
• D894R4430: MUA Lab Analog BL 2.9
• D894R4420: MUA Healing Cap BL 2.9
• D894R4410: MUA Impression Coping BL 2.9
• D894R4390: MUA Waxing Screw BL 2.9
• D894R4380: MUA Coping Screw BL 2.9
• D894R4370: MUA Castable Coping BL 2.9
• D894R4360: MUA Bar Coping BL 2.9
• D894R4350: MUA Temporary Coping BL 2.9
• D894R4340: 30° Multi-unit Abutment BL 2.9 H6
• D894R4330: 30° Multi-unit Abutment BL 2.9 H5
• D894R4320: 30° Multi-unit Abutment BL 2.9 H4
• D894R4310: 30° Multi-unit Abutment BL 2.9 H3
• D894R4300: 17° Multi-unit Abutment BL 2.9 H6
• D894R4290: 17° Multi-unit Abutment BL 2.9 H5
• D894R4280: 17° Multi-unit Abutment BL 2.9 H4
• D894R4270: 17° Multi-unit Abutment BL 2.9 H3
• D894R4250: Angled MUA (Multi-unit Abutment) Retention Screw BL 2.9
• D894R4240: Multi-unit Abutment BL 2.9 H6
• D894R4230: Multi-unit Abutment BL 2.9 H5
• D894R4220: Multi-unit Abutment BL 2.9 H4
• D894R4210: Multi-unit Abutment BL 2.9 H3