3d Dental-Essentials

3D Dental LAB Coat Ceil Blue X-Large 10/PKG

Registry build 21.09.26
318manufacturers in China registered for this device type
56catalogue numbers in this listing

Who Else Makes It

Concentrated in Hubei (71), Jiangsu (59), Zhejiang (42). 83 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OEA
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Anqing Kangmingna Packaging Co., Ltd. Anqing Anhui Contract manufacturer 39
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Taizhou Xinkang Medical Materials Co., Ltd. Taizhou Jiangsu Contract manufacturer 35
Jiangsu Guangda Medical Material Group Co., Ltd. Haian Jiangsu Contract manufacturer 32
Evereast Medical Products Group Co., Ltd. Changyuan Henan Contract manufacturer 30
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Zhongshan Chukuang Textile Co., Ltd. Zhongshan Guangdong Contract manufacturer 26
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. Jingmen Hubei Contract manufacturer 23

Showing 12 of 318. All 318 manufacturers in China registered for Non-Surgical Gown

Record

Regulatory record for 3D Dental-Essentials
Listed by 3D Dental Designs AND Development, LLC
FDA product code OEA
Device type Non-Surgical Gown
Device class Class 1
Regulation 21 CFR 878.4040
Premarket notification Exempt
Record published 2023-02-21
Record revised 2025-12-17 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Label carries lot or batch number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for 3D Dental-Essentials
Catalogue number Size Status
DLJ-PPM In distribution
DJ-SBL In distribution
DJ-SBL In distribution
DJ-PKL In distribution
DJ-PPS In distribution
DLJ-SBS In distribution
DLJ-PKM In distribution
DJ-SBM In distribution
DJ-PKM In distribution
DLJ-SBM In distribution
DLJ-PPS In distribution
DJ-SBM In distribution
DLJ-CBXL In distribution
DLJ-CBL In distribution
DJ-SBXL In distribution
DJ-PKXL In distribution
DLJ-SBS In distribution
DJ-PKS In distribution
DLJ-PKS In distribution
DLJ-PPL In distribution
DLJ-CBS In distribution
DLJ-PPM In distribution
DJL-SBL In distribution
DLJ-PKL In distribution
DJ-PKS In distribution
DLJ-CBS In distribution
DJ-PPXL In distribution
PKXL In distribution
DJ-PPM In distribution
DLJ-SBXL In distribution
DJ-PPL In distribution
DJ-PPL In distribution
DJ-CBXL In distribution
DLJ-CBXL In distribution
DJ-CBM In distribution
DJ-SBS In distribution
DJ-SBS In distribution
DLJ-SBL In distribution
DJ-PPS In distribution
DJ-PKM In distribution
DLJ-PPL In distribution
DJ-CBXL In distribution
DLJ-PPXL In distribution
DJ-SBXL In distribution
DLJ-PPS In distribution
DLJ-CBL In distribution
DLJ-PKXL In distribution
DJ-PPXL In distribution
DLJ-PKM In distribution
DLJ-PKL In distribution
DLJ-SBXL In distribution
DLJ-CBM In distribution
DLJ-SBM In distribution
DLJ-PKS In distribution
DLJ-SBL In distribution
DJ-PPM In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 230
Henry Schein Henry Schein, Inc. 144
Darby Dental Supply, LLC Darby Dental Supply, LLC 118
Medline Medline Industries, Inc. 99
Precaution/Isolation Gown Standard Textile Co., Inc. 83
PremierPro Prestige Ameritech 74
Alleset GRI Medical & Electronic Technology Co., Ltd. 71
Medicom Safewear AMD Medicom Inc. 70
Maytex Maytex Corp. 67
Precept® Precept Medical Products, Inc. 61
Halyard O&M Halyard, Inc. 53
AMD-Ritmed AMD Medicom Inc. 42

Showing 12 of 230. All products under Non-Surgical Gown

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