Integra® Miltex®

Precision™ Parallel Sided Post, Size 5.5, Stainless Steel, Vented - 100 Pack

Registry build 21.09.26
10manufacturers in China registered for this device type
37catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (3), Jiangsu (2), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ELR
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Shanghai Alwings Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 39
Henan Lusterdent Medical Instrument Co., Ltd. Zhengzhou Henan Manufacturer 15
Shanghai Fanta Dental Materials Co., Ltd. Shanghai Shanghai Manufacturer 15
Shenzhen Forever Medical Devices Co., Ltd. Shenzhen Guangdong Contract manufacturer 9

Record

Regulatory record for Integra® Miltex®
Listed by Integra LifeSciences Production Corporation, United States
FDA product code ELR
Device type Post, Root Canal
Device class Class 1
Regulation 21 CFR 872.3810
Establishment Contract manufacturer, Specification developer, Manufacturer
Premarket notification Exempt
Record published 2018-07-03
Record revised 2020-11-02 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number
Distribution end date 2022-05-01

Catalogue Numbers

Catalogue numbers for Integra® Miltex®
Catalogue number Size Per pack Status
700001-0007-001 10 Withdrawn
700003-0003-001 10 Withdrawn
700004-0001-001 100 Withdrawn
012-12402 10 Withdrawn
012-50050 2 Withdrawn
700002-0004-001 100 Withdrawn
700002-0006-001 100 Withdrawn
700002-0005-001 100 Withdrawn
700004-0005-001 100 Withdrawn
700001-0002-001 10 Withdrawn
700001-0001-001 10 Withdrawn
700004-0002-001 100 Withdrawn
700001-0003-001 10 Withdrawn
700002-0001-001 100 Withdrawn
700003-0004-001 10 Withdrawn
700003-0001-001 10 Withdrawn
012-50051 2 Withdrawn
700001-0000-001 Withdrawn
700004-0006-001 100 Withdrawn
700004-0003-001 100 Withdrawn
700002-0002-001 100 Withdrawn
700003-0002-001 10 Withdrawn
700004-0004-001 100 Withdrawn
700001-0006-001 10 Withdrawn
700002-0007-001 100 Withdrawn
700003-0005-001 10 Withdrawn
012-12401 10 Withdrawn
012-12403 10 Withdrawn
012-12404 10 Withdrawn
700001-0005-001 10 Withdrawn
700003-0006-001 10 Withdrawn
700003-0007-001 10 Withdrawn
700002-0003-001 100 Withdrawn
700001-0004-001 10 Withdrawn
700002-0000-001 Withdrawn
012-12400 Withdrawn
700004-0007-001 100 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Henry Schein Henry Schein, Inc. 115
ParaPost XP Coltene/Whaledent Gmbh & Co. KG 111
Darby Dental Supply, LLC Darby Dental Supply, LLC 90
Hahnenkratt E. Hahnenkratt Gmbh 89
Surtex Dentatus AB 84
ParaPost Coltene/Whaledent Gmbh & Co. KG 46
Brasseler USA Peter Brasseler Holdings, LLC 44
Two Striper Abrasive Technology, LLC 43
Johnson-Promident Young Innovations Inc. 41
Flexi-Post Essential Dental Systems, Inc. 40
Biolight Synca Marketing 37
Endodontic Posts Rhein 83 SRL 31

Showing 12 of 231. All products under Post, Root Canal

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