What is FDA product code NYC?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.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 › SurgicalDental Prophylaxis Kit

Root Canal Instruments Kit

Name: Root Canal Instruments Kit
Brand: Root Canal Instruments Kit

Catalogue number DY21-1, listed by Denjoy Dental Co., Ltd., China, under Dental Prophylaxis Kit. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Hunan.

Chinese manufacturers registered for FDA product code NYC
Manufacturer	City	Province	Registered as	Device types
Denjoy Dental Co., Ltd.	Changsha	Hunan	Contract manufacturer	17

Record

Regulatory record for Root Canal Instruments Kit
Listed by	Denjoy Dental Co., Ltd., China
FDA product code	NYC
Device type	Dental Prophylaxis Kit
Device class	Class 1
Regulation	21 CFR 872.4565
Establishment	Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2022-02-19
Record revised	2024-02-05 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Root Canal Instruments Kit
Catalogue number	Size	Status
DY21-1		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Instrapac	Robinson Healthcare Limited	13
Aligner Treatment Starter Kitz	Orthonu, LLC	1
SureSmile®	Dentsply Sirona Orthodontics Inc.	1
Braces Treatment Starter Kitz	Orthonu, LLC	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.