Waterpik Krex Z.O.E. Impression Corrective Paste

Zinc oxide eugenol impression corrective paste, Type II medium-bodied, economy size

Registry build 21.09.26
6manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Jiangxi (1), Hunan (1).

Chinese manufacturers registered for FDA product code EMB
Manufacturer City Province Registered as Device types
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Nanchang White Technology Co., Ltd. Nanchang Jiangxi Contract manufacturer 21
Changsha Easyinsmile Intelligence Technology Co., Ltd. Changsha Hunan Manufacturer 15
Changshu Shangchi Dental Materials Co., Ltd. Changshu Jiangsu Manufacturer 3
Shanghai Rong Xiang Dental Material Company Limited Shanghai Shanghai Contract manufacturer 1

Record

Regulatory record for Waterpik Krex Z.O.E. Impression Corrective Paste
Listed by Water PIK, Inc., United States
FDA product code EMB
Device type Zinc Oxide Eugenol
Device class Class 1
Regulation 21 CFR 872.3275
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2020-08-31
Record revised 2025-09-16 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Storage Storage environment temperature 68 to 77 °F
Sizes Weight 65 to 139 g
Distribution end date 2025-09-15

Catalogue Numbers

Catalogue numbers for Waterpik Krex Z.O.E. Impression Corrective Paste
Catalogue number Size Status
015100-000 Weight 80 g Withdrawn
015101-000 Weight 139 g Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Maquira Maquira Industria de Produtos Odontologicos S/A 6
Ceka & Preci-Line Attachments Alphadent Co., Ltd. 4
DiaCemTempNE Diadent Group Intl., Inc. 4
ZOE B&T® Base and Temporary Filling Material Dentsply LLC 3
Integra® Miltex® Integra LifeSciences Production Corporation 3
Mizzy Keystone Industries 3
Zinconol Prevest Denpro Limited 3
SciPharm NeoZoe, Temporary Cement Scientific Pharmaceuticals, Inc. 2
Nobil Metal SPA Nobil Metal SPA 2
Zinc Oxide U.S.P. Dentsply LLC 2
Embonte + Kerr Corporation 2
TempoCem® Automix DMG Chemisch Pharmazeutische Fabrik Gmbh 2

Showing 12 of 57. All products under Zinc Oxide Eugenol

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer