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SCOTT'S SELECT HYDROCLONE™ VPS HP REG-SET MONOPHASE 4/bx BERRY

FDA UDI

Class II (US FDA UDI)

by Scott's Dental Supply L.l.c.

Identity

Trade Name
SCOTT'S SELECT HYDROCLONE™ VPS HP REG-SET MONOPHASE 4/bx BERRY FDA UDI
Generic Name
Silicone dental impression material FDA UDI
Device Name
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. Delivery method: dispensing cartridge, regular set, monophase, berry flavor. SDS and instructions for use available at https://www.scottsdental.com/hydro-clone-vps.html FDA UDI
Model / Reference
104-7228 FDA UDI
Description
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. Delivery method: dispensing cartridge, regular set, monophase, berry flavor. SDS and instructions for use available at https://www.scottsdental.com/hydro-clone-vps.html FDA UDI

Identifiers

Catalog Number
104-7228 FDA UDI
Primary DI / UDI-DI
D77810472281 FDA UDI
FDA Product Code
ELW FDA UDI
GMDN Term
Silicone dental impression material FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 50 Milliliter FDA UDI

Category: Silicone dental impression material

SCOTT'S SELECT HYDROCLONE™ VPS HP REG-SET MONOPHASE 4/bx BERRY by Scott's Dental Supply L.l.c. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Silicone dental impression material.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 71aa4143-7465-4df2-a34d-69d65393c819 37 fields · synced May 30, 2026