BenTips Shaft 45Av1

GUDID D966S45AV10

BenTips shaft designed and configured to connect the piezosurgery handpiece to the PEEK tips.

BENNETT JACOBY, DDS, MS, INC.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: D966S45AV10
• NIH Device Record Key: 2e120c97-e622-4686-9021-c7a81441041b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BenTips Shaft 45Av1
• Version Model Number: S45Av1
• 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: true
• 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	D966S45AV10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192033

FDA Product Code

• DZI: Drill, Bone, Powered

Sterilization

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

[D966S45AV10]

Moist Heat or Steam Sterilization

[D966S45AV10]

Moist Heat or Steam Sterilization

[D966S45AV10]

Moist Heat or Steam Sterilization

[D966S45AV10]

Moist Heat or Steam Sterilization

[D966S45AV10]

Moist Heat or Steam Sterilization

[D966S45AV10]

Moist Heat or Steam Sterilization

[D966S45AV10]

Moist Heat or Steam Sterilization

[D966S45AV10]

Moist Heat or Steam Sterilization

[D966S45AV10]

Moist Heat or Steam Sterilization

[D966S45AV10]

Moist Heat or Steam Sterilization

[D966S45AV10]

Moist Heat or Steam Sterilization

[D966S45AV10]

Moist Heat or Steam Sterilization

[D966S45AV10]

Moist Heat or Steam Sterilization

[D966S45AV10]

Moist Heat or Steam Sterilization

[D966S45AV10]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-09
• Device Publish Date: 2021-11-01

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