Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40ST

Q: What is the product code of K132356?

The FDA product code is EGS – Handpiece, Contra- And Right-Angle Attachment, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.

FDA 510(k) K132356 · Scican GmbH

Substantially Equivalent

510(k) numberK132356

Submission

Device name: Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40ST
Applicant: Scican GmbH
Leutkirch, DE
Received: July 29, 2013
Decision date: January 31, 2014
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: EGS – Handpiece, Contra- And Right-Angle Attachment, Dental
Device class: Class I (low risk)
Regulation: 21 CFR 872.4200
Specialty: Dental

Other 510(k)s with product code EGS

510(k)	Device	Applicant	Decision
K251869	Disposable Prophy Angle (3399-60, 3399-090, 3399-105)EGS · Traditional	Premium Plus (Dongguan) Limited	09/15/2025SE
K240950	Disposable Prophy AngleEGS · Abbreviated	Pacific Care Limited	05/28/2025SE
K240183	Star E900 Handpiece SeriesEGS · Traditional	Dentalez, Inc., Stardental Division	09/19/2024SE
K230106	General Cutting StraightEGS · Traditional	Nakanishi, Inc.	05/24/2023SE
K222518	FX ContraEGS · Traditional	Nakanishi, Inc.	11/17/2022SE
K220874	Smooth Drive contra angle and straight handpiecesEGS · Traditional	Lares Research	11/07/2022SE
K220346	Lotus Prophy AngleEGS · Traditional	Ajk Engineering, Inc.	11/07/2022SE
K220577	Dental Handpiece, Model CA160, CA160L, and CA500LEGS · Traditional	Micro-Nx Co., Ltd.	07/29/2022SE
K213139	SURGmatic S15 L ProEGS · Traditional	Kavo Dental GmbH	12/21/2021SE
K202960	General Cutting Contra HandpieceEGS · Special	Nakanishi, Inc.	10/27/2020SE

More from Nakanishi, Inc.

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K190062	STATCLAVE G4 Chamber AutoclaveFLE · Abbreviated	07/26/2019SE
K172292	SALUS - Hygiene Instrument Reprocessing ContainerKCT · Abbreviated	11/24/2017SE
K112872	Statim 2000 G4 CassetteFLE · Special	07/10/2012SE
K090937	E-Statis 40 SystemEBW · Traditional	07/24/2009SE
K090265	Bravo Autoclave, Models 17, 17V and 21VFLE · Abbreviated	05/15/2009SE
K073319	Statmatic 31 Handpiece Maintenance UnitEFB · Traditional	02/04/2008SE
K072466	Statim 7000 (Without Usb Port), Model 01-702100, Statim 7000 (with Usb Port), Model…FLE · Traditional	12/19/2007SE

Questions and answers

When was Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40ST cleared by the FDA?

Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40ST (K132356) received a 510(k) decision of Substantially Equivalent on January 31, 2014, 186 days after the submission was received.

What is the product code of K132356?

The FDA product code is EGS – Handpiece, Contra- And Right-Angle Attachment, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.