Integra® Miltex®

Integra® Miltex® Woodson Plastic Filling Instrument 7", No. 1, Double-Ended, Octagonal Handle

Registry build 21.09.26
23manufacturers in China registered for this device type
41catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (5), Guangdong (5), Anhui (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EIY
Manufacturer City Province Registered as Device types
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Hefei Xingcheng Sanitary Products Co., Ltd. Hefei Anhui Contract manufacturer 21
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Zhejiang Lidesen Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 100
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Huanghua Promisee Dental Co., Ltd. Huanghua Hebei Manufacturer 54
Shanghai Hua En Industrial Co Ltd Shanghai Shanghai Contract manufacturer 52
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
TF NEW Material SCI AND TEC Co., Ltd. Huainan Anhui Manufacturer 51

Showing 12 of 23. All 23 manufacturers in China registered for Instrument, Filling, Plastic, Dental

Record

Regulatory record for Integra® Miltex®
Listed by Integra LifeSciences Production Corporation, United States
FDA product code EIY
Device type Instrument, Filling, Plastic, Dental
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Contract manufacturer, Specification developer, Manufacturer
Premarket notification Exempt
Record published 2018-04-18
Record revised 2023-04-28 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number
Sizes Length 7 in
Distribution end date 2023-12-04

Catalogue Numbers

Catalogue numbers for Integra® Miltex®
Catalogue number Size Status
70-190 In distribution
70-184 6-1/2″ In distribution
70-180 In distribution
70-196 In distribution
70-194 In distribution
70-186 In distribution
70-182 6-3/4″ In distribution
70-188 Length 7 in In distribution
70-192 In distribution
017-37523 Withdrawn
TNPLP8 Withdrawn
TNWD3 Withdrawn
TNFP3 Withdrawn
TNPA2A-KK Withdrawn
TN12LX Withdrawn
TNPL3 Withdrawn
TNPA2A Withdrawn
TNPL12L Withdrawn
TNGL1 Withdrawn
TNWD1 Withdrawn
80-6112 Withdrawn
TNBO3-GW Withdrawn
TNGR45 Withdrawn
TNWD2 Withdrawn
TNCA12 Withdrawn
TNPL57 Withdrawn
TNWD3X-DA Withdrawn
TNPFI13 Withdrawn
TNPL2 Withdrawn
TNPL1 Withdrawn
TNPL8A Withdrawn
TN12LX-DA Withdrawn
TNGU7 Withdrawn
TNPLP8-KA Withdrawn
TNGL1BLB Withdrawn
TNPL4 Withdrawn
TNPFID4 Withdrawn
RNCA12 Withdrawn
TNPA3 Withdrawn
TNBO3-KG Withdrawn
RNJA1 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hu-Friedy HU-Friedy MFG Co., LLC 355
Power Dental USA Power Dental U.S.A. Inc. 111
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 107
Reicodent Devemed Gmbh 91
American Eagle Instruments American Eagle Instruments 79
Stoma® Storz AM Mark Gmbh 77
Zoll-Dental Zoll-Dental 69
Aesculap Aesculap AG 60
devemed Devemed Gmbh 58
Osung MND Osung MND Co., Ltd. 57
Karl Schumacher Karl Schumacher Dental, LLC 38
A. Titan Instruments A. Titan Instruments, Inc. 34

Showing 12 of 109. All products under Instrument, Filling, Plastic, Dental

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