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

Angel Aligner

Name: Angel Aligner
Brand: Angel Aligner

Catalogue number EAB II, listed by Wuxi EA Medical Instruments Technologies Limited, China, under Dental Hygiene Kit. 12 manufacturers in China are registered for this product code.

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 Angel Aligner
Listed by	Wuxi EA Medical Instruments Technologies Limited, China
FDA product code	NXZ
Device type	Dental Hygiene Kit
Device class	Class 1
Regulation	21 CFR 872.6855
Establishment	Repacker / relabeller, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2026-02-04

Specifications

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

Catalogue Numbers

Catalogue numbers for Angel Aligner
Catalogue number	Size	Status
EAB II		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
Oral Relief Kitz	Orthonu, LLC	1
P&P Medical Surgical LLC	P&P Medical Surgical 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.