BenTips Piezosurgery Handpiece

GUDID D966HBPS1LED0

BenTips Piezosurgery Handpiece

BENNETT JACOBY, DDS, MS, INC.

Dental ultrasonic surgical system handpiece Dental ultrasonic surgical system handpiece Dental ultrasonic surgical system handpiece Dental ultrasonic surgical system handpiece Dental ultrasonic surgical system handpiece Dental ultrasonic surgical system handpiece Dental ultrasonic surgical system handpiece Dental ultrasonic surgical system handpiece Dental ultrasonic surgical system handpiece Dental ultrasonic surgical system handpiece Dental ultrasonic surgical system handpiece Dental ultrasonic surgical system handpiece Dental ultrasonic surgical system handpiece Dental ultrasonic surgical system handpiece Dental ultrasonic surgical system handpiece Dental ultrasonic surgical system handpiece

• Primary Device ID: D966HBPS1LED0
• NIH Device Record Key: 29cb95e5-b2b8-4ac5-aba8-1f9c7b82d563
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BenTips Piezosurgery Handpiece
• Version Model Number: HBPS1LED0
• 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: false
• 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	D966HBPS1LED0 [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

[D966HBPS1LED0]

Moist Heat or Steam Sterilization

[D966HBPS1LED0]

Moist Heat or Steam Sterilization

[D966HBPS1LED0]

Moist Heat or Steam Sterilization

[D966HBPS1LED0]

Moist Heat or Steam Sterilization

[D966HBPS1LED0]

Moist Heat or Steam Sterilization

[D966HBPS1LED0]

Moist Heat or Steam Sterilization

[D966HBPS1LED0]

Moist Heat or Steam Sterilization

[D966HBPS1LED0]

Moist Heat or Steam Sterilization

[D966HBPS1LED0]

Moist Heat or Steam Sterilization

[D966HBPS1LED0]

Moist Heat or Steam Sterilization

[D966HBPS1LED0]

Moist Heat or Steam Sterilization

[D966HBPS1LED0]

Moist Heat or Steam Sterilization

[D966HBPS1LED0]

Moist Heat or Steam Sterilization

[D966HBPS1LED0]

Moist Heat or Steam Sterilization

[D966HBPS1LED0]

Moist Heat or Steam Sterilization

[D966HBPS1LED0]

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