Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,

Q: What is the product code of K022505?

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) K022505 · Nouvag AG

Substantially Equivalent

510(k) numberK022505

Submission

Device name: Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,
Applicant: Nouvag AG
Gebenstorf, CH
Received: July 29, 2002
Decision date: October 1, 2003
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

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

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K081191	TCM Endo 20EKX · Traditional	08/07/2008SE
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K042822	TCM Endo V, Model 1534EKX · Traditional	12/22/2004SE
K042943	Nouvag AG - Vacuson 40 and Vacuson 60BTA · Traditional	12/17/2004SE
K042434	Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55DZI · Traditional	11/03/2004SE
K013185	TCM Endo IIIEFA · Traditional	11/28/2001SE
K000710	MD 10, Sem, SM 12, CBMEFB · Traditional	05/11/2000SE
K981679	TCM 3000 and TCM EndoEFB · Traditional	02/09/1999SE

Questions and answers

When was Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, cleared by the FDA?

Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, (K022505) received a 510(k) decision of Substantially Equivalent on October 1, 2003, 429 days after the submission was received.

What is the product code of K022505?

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.