SONUS V A52000

GUDID 00862872000355

Dental magnetostrictive scaler 18 K, with four (4) M series tips (2 - M1 and 2 M2 or M4) insert and nose cone.

ENGLER ENGINEERING CORPORATION

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• Primary Device ID: 00862872000355
• NIH Device Record Key: 6cf70ae3-6a9b-439a-a436-0ecfa86d0458
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SONUS V
• Version Model Number: Sonus V
• Catalog Number: A52000
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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: 9 Inch
• Width: 7.5 Inch
• Height: 3 Inch
• Weight: 8 Pound
• Length: 9 Inch
• Width: 7.5 Inch
• Height: 3 Inch
• Weight: 8 Pound
• Length: 9 Inch
• Width: 7.5 Inch
• Height: 3 Inch
• Weight: 8 Pound
• Length: 9 Inch
• Width: 7.5 Inch
• Height: 3 Inch
• Weight: 8 Pound
• Length: 9 Inch
• Width: 7.5 Inch
• Height: 3 Inch
• Weight: 8 Pound
• Length: 9 Inch
• Width: 7.5 Inch
• Height: 3 Inch
• Weight: 8 Pound
• Length: 9 Inch
• Width: 7.5 Inch
• Height: 3 Inch
• Weight: 8 Pound
• Length: 9 Inch
• Width: 7.5 Inch
• Height: 3 Inch
• Weight: 8 Pound
• Length: 9 Inch
• Width: 7.5 Inch
• Height: 3 Inch
• Weight: 8 Pound
• Length: 9 Inch
• Width: 7.5 Inch
• Height: 3 Inch
• Weight: 8 Pound
• Length: 9 Inch
• Width: 7.5 Inch
• Height: 3 Inch
• Weight: 8 Pound
• Length: 9 Inch
• Width: 7.5 Inch
• Height: 3 Inch
• Weight: 8 Pound
• Length: 9 Inch
• Width: 7.5 Inch
• Height: 3 Inch
• Weight: 8 Pound
• Length: 9 Inch
• Width: 7.5 Inch
• Height: 3 Inch
• Weight: 8 Pound
• Length: 9 Inch
• Width: 7.5 Inch
• Height: 3 Inch
• Weight: 8 Pound
• Length: 9 Inch
• Width: 7.5 Inch
• Height: 3 Inch
• Weight: 8 Pound

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862872000355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811396

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

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

Devices Manufactured by ENGLER ENGINEERING CORPORATION

• 00862872000300 - Sonus: 2021-05-12 Dental scaling tip - rounded point for Engler insert A47030
• 00862872000317 - Sonus: 2021-05-12 Dental scaling tip - fine point for use with the Engler A47030 Insert
• 00862872000324 - Sonus M4: 2021-05-12 Dental scaling tip - broad spatula style to screw into Engler insert A47030
• 00862872000331 - Sonus Stack (Insert): 2021-05-12 Sonus 18K magnetostrictive insert with threads for interchangeable tips for the Sonus V dental device
• 00862872000348 - Sonus Nose Cone: 2021-05-12 White plastic nose cone which slips over tip and provides means of tightening tip to insert. (For use with Sonus V device)
• 00862872000355 - SONUS V: 2021-05-12Dental magnetostrictive scaler 18 K, with four (4) M series tips (2 - M1 and 2 M2 or M4) insert and nose cone.
• 00862872000355 - SONUS V: 2021-05-12 Dental magnetostrictive scaler 18 K, with four (4) M series tips (2 - M1 and 2 M2 or M4) insert and nose cone.
• 00862872000362 - Engler 25K Series: 2021-05-12 Dental 25K magnetostrictive insert with pointed tip
• 00862872000379 - Engler 25K Series: 2021-05-12 Dental 25K magnetostrictive insert with broad spatula tip