DEVICE: Alpha-Etch® 37 (D73550100050020)

Device Identifier (DI) Information

Alpha-Etch® 37
501.0005.002
In Commercial Distribution
501.0005.002
DENTAL TECHNOLOGIES, INC.
D73550100050020
HIBCC

4
148312838 *Terms of Use
Alpha-Etch® 37 is a 37% phosphoric acid etchant designed for use on both dentin and enamel. The ideal viscosity of the gel formula stays where placed and will not flow onto exposed surrounding tissue. All formulas rinse away clean without leaving any residue. Available in blue and green color. Kit Contains: 4 x 4g Syringe (Blue), 20 Syringe Tips
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Device Characteristics

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

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Size Type Text
No Device Sizes
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Device Record Status

b44581fe-f2c7-4783-bd5e-8cebadb0f830
July 06, 2018
3
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: D73550101040020 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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