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

Aligner Treatment Starter Kitz

Name: Aligner Treatment Starter Kitz
Brand: Aligner Treatment Starter Kitz

A Kit with 5 products including Tweakz for Aligners, comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips.

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 Aligner Treatment Starter Kitz
Listed by	Orthonu, LLC, United States
FDA product code	NYC
Device type	Dental Prophylaxis Kit
Device class	Class 1
Regulation	21 CFR 872.4565
Establishment	Manufacturer
Record published	2025-06-04

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, serial number

Catalogue Numbers

Catalogue numbers for Aligner Treatment Starter Kitz
Catalogue number	Size	Status
0850035489		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Instrapac	Robinson Healthcare Limited	13
Root Canal Instruments Kit	Denjoy Dental Co., Ltd.	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.