What is FDA product code NXZ?

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 › MiscellaneousDental Hygiene Kit

Oral Relief Kitz

Name: Oral Relief Kitz
Brand: Oral Relief Kitz

A Kit with 4 products including comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips.

Registry build 21.09.26

12manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Guangdong (4), Jiangsu (3), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NXZ
Manufacturer	City	Province	Registered as	Device types
Amsino Medical (Shanghai) Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	22
Zhejiang Mediunion Healthcare Group Co., Ltd.	Ningbo	Zhejiang	Contract manufacturer	105
Hubei Qianjiang Kingphar Medical Material Co., Ltd.	Qianjiang	Hubei	Contract manufacturer	52
Jiangsu JianYu Health Medical Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	35
CDM Center OF Excellence Ltd.	Beijing	Beijing	Manufacturer	29
Zhongshan BestClean Technology Co., Ltd.	Zhongshan	Guangdong	Manufacturer	12
Shenzhen Baotonghui Industrial Co., Ltd.	Shenzhen	Guangdong	Manufacturer	11
Shumei Industrial (Hebei) Co., Ltd.	Cangzhou	Hebei	Contract manufacturer	10
Shenzhen Golden Wish Personal Care Co., Ltd.	Shenzhen	Guangdong	Manufacturer	10
Junhe Industry AND Trade Co., Ltd.	Yangjiang	Guangdong	Manufacturer	8
Yangzhou Super J Toothbrush Co., Ltd.	Guangling District	Jiangsu	Manufacturer	8
Wuxi EA Medical Instruments Technologies Limited	Wuxi	Jiangsu	Repacker / relabeller	6

Record

Regulatory record for Oral Relief Kitz
Listed by	Orthonu, LLC, United States
FDA product code	NXZ
Device type	Dental Hygiene Kit
Device class	Class 1
Regulation	21 CFR 872.6855
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2025-04-27

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 Oral Relief Kitz
Catalogue number	Size	Status
850035489055		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Plak-Vac	Trademark Medical, L.L.C.	134
Centurion	Centurion Medical Products Corporation	15
Bosma Enterprises	Bosma Enterprises	5
Stradis	Stradis Healthcare	5
Medline Industries	Medline Industries, Inc.	2
Stradis Healthcare	Stradis Healthcare	2
Medline	Medline Industries, Inc.	2
P&P Medical Surgical LLC	P&P Medical Surgical LLC	1
Angel Aligner	Wuxi EA Medical Instruments Technologies Limited	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.