BenTips Insert WPUI3A

GUDID D966WPUI3A0

BenTips Insert WPUI3A

BENNETT JACOBY, DDS, MS, INC.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: D966WPUI3A0
• NIH Device Record Key: d0946370-b552-4816-9413-5c02dfac4ef6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BenTips Insert WPUI3A
• Version Model Number: WPUI3A
• 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	D966WPUI3A0 [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

[D966WPUI3A0]

Moist Heat or Steam Sterilization

[D966WPUI3A0]

Moist Heat or Steam Sterilization

[D966WPUI3A0]

Moist Heat or Steam Sterilization

[D966WPUI3A0]

Moist Heat or Steam Sterilization

[D966WPUI3A0]

Moist Heat or Steam Sterilization

[D966WPUI3A0]

Moist Heat or Steam Sterilization

[D966WPUI3A0]

Moist Heat or Steam Sterilization

[D966WPUI3A0]

Moist Heat or Steam Sterilization

[D966WPUI3A0]

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

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• 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: 2021-08-25BenTips Insert WPUI3A
• D966WPUI3A0 - BenTips Insert WPUI3A: 2021-08-25 BenTips Insert WPUI3A