ENGLER ENGINEERING CORPORATION

Address:1099 E 47th St,HIALEAH,FL,33013,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Scaler, Ultrasonic (ELC) (8)

Premarket Exempt

Clear

Sonus - 00862872000300 Catalog Number : 133-1201

Device Description : Dental scaling tip - rounded point for Engler insert A47030

Device Class : 2

Duns Number: 002965168

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Sonus - 00862872000317 Catalog Number : 133-1202

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

Device Class : 2

Duns Number: 002965168

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Sonus M4 - 00862872000324 Catalog Number : 133-1204

Device Description : Dental scaling tip - broad spatula style to screw into Engler insert A47030

Device Class : 2

Duns Number: 002965168

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Sonus Stack (Insert) - 00862872000331 Catalog Number : A47030

Device Description : Sonus 18K magnetostrictive insert with threads for interchangeable tips for the Sonus 18K magnetostrictive insert with threads for interchangeable tips for the Sonus V dental device

Device Class : 2

Duns Number: 002965168

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Sonus Nose Cone - 00862872000348 Catalog Number : 806-1105

Device Description : White plastic nose cone which slips over tip and provides means of tightening ti White plastic nose cone which slips over tip and provides means of tightening tip to insert. (For use with Sonus V device)

Device Class : 2

Duns Number: 002965168

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

SONUS V - 00862872000355 Catalog Number : A52000

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

Device Class : 2

Duns Number: 002965168

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Engler 25K Series - 00862872000362 Catalog Number : A70101

Device Description : Dental 25K magnetostrictive insert with pointed tip

Device Class : 2

Duns Number: 002965168

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Engler 25K Series - 00862872000379 Catalog Number : A70104

Device Description : Dental 25K magnetostrictive insert with broad spatula tip

Device Class : 2

Duns Number: 002965168

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

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