DEVICE: Alpha-Dent® Alginate Impression Material (D73560301030010)
Device Identifier (DI) Information
Alpha-Dent® Alginate Impression Material
603.0103.001
In Commercial Distribution
603.0103.001
DENTAL TECHNOLOGIES, INC.
603.0103.001
In Commercial Distribution
603.0103.001
DENTAL TECHNOLOGIES, INC.
Alpha-Dent® Alginate Impression Material is available in a variety of flavors and set types. This heavy body material is designed to produce consistent impressions. Each can includes powder scoop and vial.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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35863 | Alginate dental impression material |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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ELW | Material, Impression |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K790595 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 22 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9b5d6a04-7eb7-4b94-b5ef-fa5e5323e58f
July 06, 2018
3
September 23, 2016
July 06, 2018
3
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
847-677-5500
info@dentaltech.com
info@dentaltech.com