Smart Dent ®

Smart Print Model Plus is a light-curing resin intended for the additive manufacturing of dental working and presentation models using compatible DLP/LCD 3D printing systems. The material…

Registry build 21.09.26

Smart Print Model Plus is a light-curing resin intended for the additive manufacturing of dental working and presentation models using compatible DLP/LCD 3D printing systems. The material is supplied as a ready-to-use liquid resin for the fabrication of dental models for use in dental laboratory procedures. The printed models are intended exclusively for extraoral use. Smart Print Model Plus is intended exclusively for professional use.

41manufacturers in China registered for this device type
17catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (11), Guangdong (8), Shanghai (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 EBH
Manufacturer City Province Registered as Device types
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Suzhou Pac-Dent Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 26
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
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
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Anqing Clean Dental Instrument Technology Co., Ltd. Anqing Anhui Manufacturer 50
Dongguan Wanjin Industrial Co., Ltd. Dongguang Guangdong Remanufacturer 41
Tangshan Zhengtong Exhibition Co., Ltd. Tangshan Hebei Manufacturer 34
Tianjin Water Source Tech Co., Ltd. Tianjin Tianjin Manufacturer 27

Showing 12 of 41. All 41 manufacturers in China registered for Material, Impression Tray, Resin

Record

Regulatory record for Smart Dent ®
Listed by Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda., Brazil
FDA product code EBH
Device type Material, Impression Tray, Resin
Device class Class 1
Regulation 21 CFR 872.3670
Establishment Manufacturer
Premarket notification Exempt
Record published 2023-10-23

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Over the counter Yes
Label carries lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Smart Dent ®
Catalogue number Size Status
SMART PRINT PRECISION MODEL 1KG In distribution
SMART PRINT L’AQUA MODEL 1KG In distribution
SMART PRINT OCHER MODEL 250GR In distribution
SMART PRINT UNIVERSAL MODEL SALMON 250GR In distribution
SMART PRINT PRECISION MODEL 250G In distribution
SMART PRINT OCHER MODEL 500G In distribution
SMART PRINT L’AQUA MODEL 250g In distribution
SMART PRINT L’AQUA MODEL 500g In distribution
SMART PRINT PRECISION MODEL 500G In distribution
SMART PRINT GUM MODEL COLOR PINK 250G In distribution
SMART PRINT TRY-IN CASTABLE 250G In distribution
SMART PRINT UNIVERSAL MODEL SALMON 100G In distribution
SMART PRINT OCHER MODEL 1KG In distribution
SMART PRINT UNIVERSAL MODEL SALMON 500G In distribution
SMART PRINT TRY-IN CASTABLE 1KG In distribution
SMART PRINT UNIVERSAL MODEL SALMON 1KG In distribution
SMART PRINT MODEL PLUS 1kg In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
COE® GC America Inc. 400
Power Dental USA Power Dental U.S.A. Inc. 56
Plasdent Plasdent Corp. 41
JMU JMU Dental, Inc 40
Vertex-Dental BV Vertex-Dental B.V. 34
COE Tray Plastic™ GC America Inc. 28
Ou Nuo Changzhou OU NUO Medical Equipment Co., Ltd. 28
Excellent Plasdent Corp. 22
Shining 3D® Hangzhou SHINING3D Dental Technology Co., Ltd. 17
Britedent Bright Supply Inc 16
iSmile Ismile Dental Products Inc. 15
Excellent-Colors Plasdent Corp. 13

Showing 12 of 197. All products under Material, Impression Tray, Resin

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