Health-Tec Alginate

Primary DI
D773290HTFS1011
Brand
Health-Tec Alginate
Company
Dental Health Products Inc
Model
290-HTFS101
Catalog number
290-HTFS101
Device description
Health-Tec Alginate, Fast Set
Published
2017-01-17
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
D773290HTFS1012PackageHIBCC12In Commercial Distribution
D773290HTFS1011PrimaryHIBCC0

GMDN Terms

TermDefinition
Alginate dental impression materialA material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.

Device Sizes

TypeValueUnit
Weight1Pound

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from moisture
Special Storage Condition, Specify00Keep out of direct sunlight
Storage Environment Temperature32 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
800-626-2163mhull@dhpi.net

Regulatory Flags

DUNS number
623191194
Device count
1
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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