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

GC Tri Plaque ID Gel™

Name: GC Tri Plaque ID Gel™
Brand: GC Tri Plaque ID Gel™

GC Tri Plaque ID Gel™ 40g tube (36 mL, approximately 130 applications)

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

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 GC Tri Plaque ID Gel™
Listed by	GC America Inc., United States
FDA product code	NYH
Device type	Plaque Disclosing Kit
Device class	Class 2
Regulation	21 CFR 872.1740
Establishment	Contract manufacturer, Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2016-08-01
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 8 to 25 °C
Sizes	Weight 40 g
Distribution end date	2016-08-06

Catalogue Numbers

Catalogue numbers for GC Tri Plaque ID Gel™
Catalogue number	Size	Status
004273	Weight 40 g	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Acteon	Sopro	64
Owandy	Sopro	3

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.