Scott’s VPS Putty 2-JARS Fast SET Mint

Hydroclone VPS addition cured silicone elastomeric impression material (VPS) meets or exceeds requirements for Type 1 impression materials specified by the American Dental Association…

Registry build 21.09.26

Hydroclone VPS addition cured silicone elastomeric impression material (VPS) meets or exceeds requirements for Type 1 impression materials specified by the American Dental Association Specification No. 19. Products are available in multiple viscosities (and as a putty) in both tubes and cartridges for use in various impression techniques. Hydroclone VPS is manufactured to preform according to specifications for work and set time at 73°F (23°C). Higher temperatures will decrease the work time and set time. Conversely, lower temperatures will extend work/set times. The shelf life of these materials is two years. During hot weather this material can be refrigerated to prevent degradation → but should be warmed to room temperature before use. Delivery method: two part putty, fast set, mint flavor.

6manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Henan (1), Shandong (1), Jiangxi (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code ELW
Manufacturer City Province Registered as Device types
Hygedent Inc. Beijing Beijing Contract manufacturer 1
Zhengzhou Huaer Electro-Optics Technology Co., Ltd. Zhengzhou Henan Contract manufacturer 21
Shandong Huge Dental Material Corporation Rizhao Shandong Manufacturer 17
Jiangxi Dentalbright Technology Co., Ltd. Jiujiang Jiangxi Contract manufacturer 12
Sunrise Dental Laboratory, Ltd. Kowloon Hong Kong Manufacturer 5
Chemoment Materials Co., Ltd. Hefei Anhui Manufacturer 3

Record

Regulatory record for Scott’s VPS Putty 2-JARS Fast SET Mint
Listed by Scott’s Dental Supply L.L.C.
FDA product code ELW
Device type Material, Impression
Device class Class 2
Regulation 21 CFR 872.3660
Record published 2017-06-02
Record revised 2020-08-26 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment temperature up to 73 °F
Sizes Total volume 600 ml

Catalogue Numbers

Catalogue numbers for Scott’s VPS Putty 2-JARS Fast SET Mint
Catalogue number Size Status
104-8021 Total Volume 600 ml In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Henry Schein Henry Schein, Inc. 164
Darby Dental Supply, LLC Darby Dental Supply, LLC 124
EXAlence™ GC America Inc. 96
MARK3 Cargus International, Inc 75
Panasil Kettenbach Gmbh & Co KG 73
Aquasil Ultra Smart Wetting® Impression Material Cartridge System Dentsply LLC 72
DentMix IPB Inc 70
Affinis Coltène/Whaledent AG 67
Take 1 Advanced Kerr Corporation 54
MDC Dental MDC Dental 49
Elastomeric Impression Material Shandong Huge Dental Material Corporation 46
Splash® DEN-MAT Holdings, LLC 44

Showing 12 of 1,245. All products under Material, Impression

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