Sonus 133-1202

GUDID 00862872000317

Dental scaling tip - fine point for use with the Engler A47030 Insert

ENGLER ENGINEERING CORPORATION

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: 00862872000317
• NIH Device Record Key: 45bbb691-c133-48d4-9054-ec4832125840
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonus
• Version Model Number: M 2
• Catalog Number: 133-1202
• Company DUNS: 002965168
• Company Name: ENGLER ENGINEERING CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Length: 1.9 Inch
• Width: 0.25 Inch
• Length: 1.9 Inch
• Width: 0.25 Inch
• Length: 1.9 Inch
• Width: 0.25 Inch
• Length: 1.9 Inch
• Width: 0.25 Inch
• Length: 1.9 Inch
• Width: 0.25 Inch
• Length: 1.9 Inch
• Width: 0.25 Inch
• Length: 1.9 Inch
• Width: 0.25 Inch
• Length: 1.9 Inch
• Width: 0.25 Inch
• Length: 1.9 Inch
• Width: 0.25 Inch
• Length: 1.9 Inch
• Width: 0.25 Inch
• Length: 1.9 Inch
• Width: 0.25 Inch
• Length: 1.9 Inch
• Width: 0.25 Inch
• Length: 1.9 Inch
• Width: 0.25 Inch
• Length: 1.9 Inch
• Width: 0.25 Inch
• Length: 1.9 Inch
• Width: 0.25 Inch
• Length: 1.9 Inch
• Width: 0.25 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862872000317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811396

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[00862872000317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00862872000317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00862872000317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00862872000317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00862872000317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00862872000317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00862872000317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00862872000317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00862872000317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00862872000317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00862872000317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00862872000317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00862872000317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00862872000317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00862872000317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00862872000317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-12
• Device Publish Date: 2021-05-04

On-Brand Devices [Sonus]

• 00862872000317: Dental scaling tip - fine point for use with the Engler A47030 Insert
• 00862872000300: Dental scaling tip - rounded point for Engler insert A47030