BenTips Piezosurgery System

GUDID D966B10

BenTips Piezosurgery System including: 1 control unit, 2 handpieces, 1 foot pedal, 1 power cord and other accessories.

BENNETT JACOBY, DDS, MS, INC.

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• Primary Device ID: D966B10
• NIH Device Record Key: b00c63a7-9999-46f6-a751-3c1fab998359
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BenTips Piezosurgery System
• Version Model Number: B1
• Company DUNS: 031283428
• Company Name: BENNETT JACOBY, DDS, MS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D966B10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111290

FDA Product Code

• DZI: Drill, Bone, Powered

Sterilization

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

[D966B10]

Moist Heat or Steam Sterilization

[D966B10]

Moist Heat or Steam Sterilization

[D966B10]

Moist Heat or Steam Sterilization

[D966B10]

Moist Heat or Steam Sterilization

[D966B10]

Moist Heat or Steam Sterilization

[D966B10]

Moist Heat or Steam Sterilization

[D966B10]

Moist Heat or Steam Sterilization

[D966B10]

Moist Heat or Steam Sterilization

[D966B10]

Moist Heat or Steam Sterilization

[D966B10]

Moist Heat or Steam Sterilization

[D966B10]

Moist Heat or Steam Sterilization

[D966B10]

Moist Heat or Steam Sterilization

[D966B10]

Moist Heat or Steam Sterilization

[D966B10]

Moist Heat or Steam Sterilization

[D966B10]

Moist Heat or Steam Sterilization

[D966B10]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-09
• Device Publish Date: 2021-04-01

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