DEVICE: Alpha-Dent® Alginate Impression Material (D73560304030010)

Device Identifier (DI) Information

Alpha-Dent® Alginate Impression Material
603.0403.001
In Commercial Distribution
603.0403.001
DENTAL TECHNOLOGIES, INC.
D73560304030010
HIBCC

1
148312838 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
ELW Material, Impression
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 22 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

528adbc6-ddcd-4d7e-8018-b9e759a5b9f3
March 29, 2018
2
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
847-677-5500
info@dentaltech.com
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