Engler 25K Series A70104

GUDID 00862872000379

Dental 25K magnetostrictive insert with broad spatula tip

ENGLER ENGINEERING CORPORATION

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

• Primary Device ID: 00862872000379
• NIH Device Record Key: 0aecc520-d149-44ec-9b26-41f73be4cdc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Engler 25K Series
• Version Model Number: S 4
• Catalog Number: A70104
• 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: 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: 7.35 Inch
• Width: 0.375 Inch
• Length: 7.35 Inch
• Width: 0.375 Inch
• Length: 7.35 Inch
• Width: 0.375 Inch
• Length: 7.35 Inch
• Width: 0.375 Inch
• Length: 7.35 Inch
• Width: 0.375 Inch
• Length: 7.35 Inch
• Width: 0.375 Inch
• Length: 7.35 Inch
• Width: 0.375 Inch
• Length: 7.35 Inch
• Width: 0.375 Inch
• Length: 7.35 Inch
• Width: 0.375 Inch
• Length: 7.35 Inch
• Width: 0.375 Inch
• Length: 7.35 Inch
• Width: 0.375 Inch
• Length: 7.35 Inch
• Width: 0.375 Inch
• Length: 7.35 Inch
• Width: 0.375 Inch
• Length: 7.35 Inch
• Width: 0.375 Inch
• Length: 7.35 Inch
• Width: 0.375 Inch
• Length: 7.35 Inch
• Width: 0.375 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862872000379 [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

[00862872000379]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00862872000379]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00862872000379]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00862872000379]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00862872000379]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00862872000379]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00862872000379]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00862872000379]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00862872000379]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00862872000379]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00862872000379]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00862872000379]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00862872000379]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00862872000379]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00862872000379]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00862872000379]

Dry Heat Sterilization;Moist Heat or Steam 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 [Engler 25K Series]

• 00862872000379: Dental 25K magnetostrictive insert with broad spatula tip
• 00862872000362: Dental 25K magnetostrictive insert with pointed tip