3m™ Espe™

3M™ ESPE™ Pedodontic Anterior Strip Crown Form, Upper Right Lateral, Size 3, 914033

Registry build 21.09.26
7manufacturers in China registered for this device type
17catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KCQ
Manufacturer City Province Registered as Device types
Hantech Medical Device Co., Ltd. Cixi Zhejiang Contract manufacturer 18
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Shanghai Dochem Industries Co., Ltd. Shanghai Shanghai Manufacturer 45
Dongguan Wanjin Industrial Co., Ltd. Dongguang Guangdong Remanufacturer 41
Tangshan Zhengtong Exhibition Co., Ltd. Tangshan Hebei Manufacturer 34
Jinyuan Medical Equipment(Tianjin)Co., Ltd. Tianjin Tianjin Contract manufacturer 27
Shaoguan Guanghua Plastic AND Hardwear Products Ltd Shaoguan Guangdong Manufacturer 2

Record

Regulatory record for 3M™ Espe™
Listed by 3M Company, United States
FDA product code KCQ
Device type Tube Impression And Matrix
Device class Class 1
Regulation 21 CFR 872.6570
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2018-09-24

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Packaging Box of 5, box of 10

Catalogue Numbers

Catalogue numbers for 3M™ Espe™
Catalogue number Size Per pack Status
914022 5 In distribution
914033 5 In distribution
914014 5 In distribution
914002 5 In distribution
914011 5 In distribution
914034 5 In distribution
914004 5 In distribution
914032 5 In distribution
914013 5 In distribution
914003 5 In distribution
914031 5 In distribution
914021 5 In distribution
914001 5 In distribution
915100 120 In distribution
914023 5 In distribution
914024 5 In distribution
914012 5 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
White Bite White Bite, Inc. 82
Hahnenkratt E. Hahnenkratt Gmbh 33
E. Hahnenkratt GmbH E. Hahnenkratt Gmbh 23
Gripper™ Soft Copper Band Parkell, Inc. 21
3D Dental 3D Dental Designs AND Development, LLC 17
Advance Dental Products THE Atlanta Dental Supply Company 7
JMU JMU Dental, Inc 4
3M™ 3M Company 1
Solventum US LLC Solventum US 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.

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