Microdont

Stainless Steel Diamond Strips with Gapped Center - 4,0 mm - Medium - Box w/06 pcs

Registry build 21.09.26
18manufacturers in China registered for this device type
28catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (7), Zhejiang (2), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code EHM
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Huanghua Promisee Dental Co., Ltd. Huanghua Hebei Manufacturer 54
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Henan Baistra Medical Devices Limited Zhengzhou Henan Manufacturer 34
Tangshan Zhengtong Exhibition Co., Ltd. Tangshan Hebei Manufacturer 34
Hangzhou Wise Medical Device Co., Ltd. Hangzhou Zhejiang Contract manufacturer 25
Unisource Shanghai Ltd. Shanghai Shanghai Reprocessor 23
Llrn Personal Care (Shenzhen) Co., Ltd. Shenzhen Guangdong Manufacturer 20
Guangxi Ehall Medical Technology Co., Ltd. Nanning Guangxi Manufacturer 17
Changsha Easyinsmile Intelligence Technology Co., Ltd. Changsha Hunan Manufacturer 15

Showing 12 of 18. All 18 manufacturers in China registered for Strip, Polishing Agent

Record

Regulatory record for Microdont
Listed by 3R – Industria E Comercio Eireli
FDA product code EHM
Device type Strip, Polishing Agent
Device class Class 1
Regulation 21 CFR 872.6010
Premarket notification Exempt
Record published 2022-01-18

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Microdont
Catalogue number Size Per pack Status
10.350.021 6 In distribution
10.304.008 12 In distribution
10.350.024 6 In distribution
10.302.008 50 In distribution
10.309.006 6 In distribution
10.309.002 6 In distribution
10.302.003 100 In distribution
10.302.009 50 In distribution
10.350.025 6 In distribution
10.304.010 12 In distribution
10.309.001 6 In distribution
10.309.003 6 In distribution
10.302.005 150 In distribution
10.302.004 150 In distribution
10.350.023 6 In distribution
10.309.004 6 In distribution
10.302.006 150 In distribution
10.302.001 100 In distribution
10.309.007 6 In distribution
10.309.005 6 In distribution
10.304.005 12 In distribution
10.304.009 12 In distribution
10.350.022 6 In distribution
10.302.007 50 In distribution
10.304.006 12 In distribution
10.302.002 100 In distribution
10.304.004 12 In distribution
10.309.008 6 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sunshine Diamonds DR. Hopf Gmbh & Co. KG 197
Horico Hopf, Ringleb & Co. Gmbh & CIE. 146
MDT Diamond Coated Dental Flexible Strips M.D.T. – Micro Diamond Technologies Ltd. 121
ContacEZ Directa AB 104
Darby Dental Supply, LLC Darby Dental Supply, LLC 95
Integra® Miltex® Integra LifeSciences Production Corporation 77
Galaxy™ Ortho Organizers, Inc. 47
NEW Metal Strips GC America Inc. 34
SpaceFile® Dentsply Sirona Orthodontics Inc. 29
Two Striper Abrasive Technology, LLC 21
Denfinity 3R – Industria E Comercio Eireli 21
Prodia Abrasive Technology, LLC 19

Showing 12 of 83. All products under Strip, Polishing Agent

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