Engler 25K Series S-1 A70101

GUDID 00636266958702

Dental 25 K insert with pointed tip

ENGLER ENGINEERING CORPORATION

Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: 00636266958702
• NIH Device Record Key: a2b8f95d-41e7-40e2-8287-ecb96d3b1b6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Engler 25K Series S-1
• Version Model Number: S 1
• Catalog Number: A70101
• Company DUNS: 002965168
• Company Name: ENGLER ENGINEERING CORPORATION
• Device Count: 1
• DM Exempt: true
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00636266958702 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122748

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[00636266958702]

Liquid Chemical;Dry Heat Sterilization

[00636266958702]

Liquid Chemical;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-09
• Device Publish Date: 2018-07-09

Devices Manufactured by ENGLER ENGINEERING CORPORATION

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• 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: 2021-05-12 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