DEVICE: Dental Etchant (Enamel Conditioner), 12g Syringe (D83600400)

Device Identifier (DI) Information

Dental Etchant (Enamel Conditioner), 12g Syringe
0040
In Commercial Distribution
0040
DENT ZAR, INC.
D83600400
HIBCC

1
789664455 *Terms of Use
Etch Gel 12 g Syringe with disposable tips, also, available for bulk purchase-1 kg bottle. Dent Zar’s etch gel is a 37% phosphoric acid solution. • Convenient dispensing system with disposable tips • Easy to wash off • Economical • Colored for precise application • Excellent wetting characteristics • Non-drying • Direct to tooth application with disposable luer-lock tips • Refillable applicator syringes
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Device Characteristics

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

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Product Code Product Code Name
EBF Material, Tooth Shade, Resin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

06c04889-e25c-4fc6-a380-969382e3bd09
March 29, 2018
2
September 04, 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
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Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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