DEVICE: ALPHA-DENT® Etchant Liquid (D73550301020010)

Device Identifier (DI) Information

ALPHA-DENT® Etchant Liquid
503.0102.001
In Commercial Distribution
503.0102.001
DENTAL TECHNOLOGIES, INC.
D73550301020010
HIBCC

1
148312838 *Terms of Use
ALPHA-DENT® Etchant Liquid is a 37% phosphoric acid etchant designed for use on both dentin and enamel. All formulas rinse away clean without leaving any residue. Available in blue or green color. Kit Contains: 1 x 15ml Bottle (Blue)
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Dental etching solution An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
KLE Agent, Tooth Bonding, Resin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K984503 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 27 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

13306ad4-f5fc-4c9e-ae73-206fbaa852e2
July 06, 2018
3
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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