What is FDA product code NYH?

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Dental › DiagnosticPlaque Disclosing Kit

Owandy

Name: Owandy
Brand: Owandy

This is an extra- and intra-oral Sopro 617 camera designed for dental applications. It allows the user to see anatomical and pathological details that cannot be seen with the naked eye, as…

Registry build 21.09.26

This is an extra- and intra-oral Sopro 617 camera designed for dental applications. It allows the user to see anatomical and pathological details that cannot be seen with the naked eye, as well as pathology control and post-treatment.

3manufacturers in China registered for this device type

3catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangxi (1), Henan (1), Guangdong (1).

Chinese manufacturers registered for FDA product code NYH
Manufacturer	City	Province	Registered as	Device types
Guilin Yikeshi Medical Device Co Ltd	Guilin	Guangxi	Manufacturer	28
Zhengzhou Huaer Electro-Optics Technology Co., Ltd.	Zhengzhou	Henan	Contract manufacturer	21
Guangzhou Stars Pulse Co., Ltd.	Guangzhou	Guangdong	Manufacturer	3

Record

Regulatory record for Owandy
Listed by	Sopro, France
FDA product code	NYH
Device type	Plaque Disclosing Kit
Device class	Class 2
Regulation	21 CFR 872.1740
Establishment	Repacker / relabeller, Manufacturer
Record published	2021-01-06

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Owandy
Catalogue number	Size	Status
OWANDY-CAM HD PAL		In distribution
MINI DOCK OWANDY-CAM HD		In distribution
OWANDY-CAM HD NTSC		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Acteon	Sopro	64
GC Tri Plaque ID Gel™	GC America Inc.	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.