Nutorque Programmable Electric System

Q: What is the product code of K083252?

The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.

FDA 510(k) K083252 · Dentalez Group, Stardental Division

Substantially Equivalent

510(k) numberK083252

Submission

Device name: Nutorque Programmable Electric System
Applicant: Dentalez Group, Stardental Division
Lancaster, PA, US
Received: November 4, 2008
Decision date: February 18, 2009
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

Official FDA 510(k) record

Device classification

Product code: EBW – Controller, Foot, Handpiece And Cord
Device class: Class I (low risk)
Regulation: 21 CFR 872.4200
Specialty: Dental

Other 510(k)s with product code EBW

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K251701	Star E900 Electric SystemEBW · Traditional	Dentalez, Inc., Stardental Division	01/12/2026SE
K251811	Motor and Apex Module (MaAM)EBW · Traditional	Dentsply Sirona, Inc.	08/25/2025SE
K231562	ELEC ENGINE (Model: ISE-170L)EBW · Special	Micro-Nx Co., Ltd.	07/18/2025SE
K242646	Dental Implant UnitEBW · Traditional	Guilin Aesthedent Medical Instruments Co., Ltd.	04/11/2025SE
K233288	NLZ Built-In Motor SystemEBW · Traditional	Nakanishi, Inc.	06/24/2024SE
K233117	Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)EBW · Traditional	Nakanishi, Inc.	06/20/2024SE
K230895	CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3…EBW · Traditional	Cefla S.C.	04/01/2024SE
K231864	Fiber Optic Brushless Electronic Micromotor, model: iM100EBW · Traditional	Codent Technical Industry Co., Ltd.	03/11/2024SE
K211358	Implanter incl. AccessoriesEBW · Traditional	Guilin Woodpecker Medical Instrument Co., Ltd.	11/21/2022SE

More from Guilin Woodpecker Medical Instrument Co., Ltd.

510(k)	Device	Decision
K130455	430 SWL 45 and 430 SW 45 High-Speed HandpiecesEFB · Traditional	09/25/2013SE

Questions and answers

When was Nutorque Programmable Electric System cleared by the FDA?

Nutorque Programmable Electric System (K083252) received a 510(k) decision of Substantially Equivalent on February 18, 2009, 106 days after the submission was received.

What is the product code of K083252?

The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.