BenTips Insert WPUI5A

GUDID D966WPUI5A0

BenTips Insert WPUI5A

BENNETT JACOBY, DDS, MS, INC.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: D966WPUI5A0
• NIH Device Record Key: 7a9caf4c-4f9e-4dc2-b9ac-1d2579d9b4dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BenTips Insert WPUI5A
• Version Model Number: WPUI5A
• Company DUNS: 031283428
• Company Name: BENNETT JACOBY, DDS, MS, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D966WPUI5A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111290

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[D966WPUI5A0]

Moist Heat or Steam Sterilization

[D966WPUI5A0]

Moist Heat or Steam Sterilization

[D966WPUI5A0]

Moist Heat or Steam Sterilization

[D966WPUI5A0]

Moist Heat or Steam Sterilization

[D966WPUI5A0]

Moist Heat or Steam Sterilization

[D966WPUI5A0]

Moist Heat or Steam Sterilization

[D966WPUI5A0]

Moist Heat or Steam Sterilization

[D966WPUI5A0]

Moist Heat or Steam Sterilization

[D966WPUI5A0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-25
• Device Publish Date: 2021-08-17

Devices Manufactured by BENNETT JACOBY, DDS, MS, INC.

• D966T15V330 - BenTips Stubby Tri A3: 2022-02-25
• D966T15V500 - BenTips Mod Tri A3: 2022-02-25
• D966T16V300 - BenTips Star A3: 2022-02-25
• D966T18V240 - BenTips OG Quad A: 2022-02-25
• D966TTA0 - BenTips TTA: 2022-02-25 T15v1.1
• D966S45AV10 - BenTips Shaft 45Av1: 2021-11-09 BenTips shaft designed and configured to connect the piezosurgery handpiece to the PEEK tips.
• D966S90AV10 - BenTips Shaft 90Av1: 2021-11-09 BenTips shaft designed and configured to connect the piezosurgery handpiece to the PEEK tips.
• D966WPUI3A0 - BenTips Insert WPUI3A: 2021-08-25 BenTips Insert WPUI3A