FDA.reportPublic FDA data

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

Primary DI
D77810472241
Brand
SCOTT'S SELECT HYDROCLONE™ VPS HP REG-SET REGULAR BODY 4/bx BERRY
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
104-7224
Catalog number
104-7224
Device 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, regular body, berry flavor. SDS and instructions for use available at https://www.scottsdental.com/hydro-clone-vps.html
Published
2017-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ELWMaterial, Impression

Product Code Classifications

CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77810472241PrimaryHIBCC0
D77810472240Unit of UseHIBCC0

GMDN Terms

TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Device Sizes

TypeValueUnit
Total Volume50Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature073 Degrees Fahrenheit
Storage Environment Temperature0 Degrees Fahrenheit73 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
8009013368info@scottsdental.com
+1(800)901-3368info@scottsdental.com

Regulatory Flags

DUNS number
137217043
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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