Diacem Tempne

This product is a non-eugenol type dental adhesive cement that corresponds to type 1 (for temporary cementation) according to the classification of ISO3107. Zinc oxide reacts with…

Registry build 21.09.26

This product is a non-eugenol type dental adhesive cement that corresponds to type 1 (for temporary cementation) according to the classification of ISO3107. Zinc oxide reacts with 2-ethoxybenzoic acid to have relatively low adhesion and strength and is used for temporary bonding.

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 Diacem Tempne
Listed by Diadent Group Intl., Inc., Canada
FDA product code EMB
Device type Zinc Oxide Eugenol
Device class Class 1
Regulation 21 CFR 872.3275
Establishment Repacker / relabeller, Private-label distributor, Manufacturer, Exporter
Premarket notification Exempt
Record published 2026-05-13

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment temperature 2 to 27 °C; Special storage condition: Keep Dry and away from Sunlight
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Diacem Tempne
Catalogue number Size Status
DIACEM TEMPNE 3g(Type S) In distribution
DIACEM TEMPNE 10g(Type S) In distribution

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
Waterpik Krex Z.O.E. Impression Corrective Paste Water PIK, Inc. 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