Elements by Hedy

Primary DI
D903HEVPSLR1
Brand
Elements by Hedy
Company
AMD Medicom Inc
Model
HE-VPSLR
Catalog number
HE-VPSLR
Device description
Dental Impression Material - Elements VPS Light Body Reg-Set Kit
Published
2018-10-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D903HEVPSLR1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material kit, single-useA collection of non-sterile devices designed to obtain a negative imprint of the teeth and/or upper palate (i.e., the roof of the mouth with the gums and teeth). It is subsequently used to make a mould for the manufacture of a custom-made dental prosthesis, orthodontic appliance, and/or oral appliance. The kit typically includes dental impression materials and a dental impression tray(s); reusable application devices are not included. Impression material is placed on the tray and the tray is then positioned in the mouth of the patient until the material becomes firm creating the mould. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905.271.1523Hamed@hedygs.com

Regulatory Flags#

DUNS number
256880576
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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