DEVICE: Etchant Gel Syringe (D867CLEGS0)

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Device Record History
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Device Identifier (DI) Information
Etchant Gel Syringe
CLEGS
Not in Commercial Distribution
CLEGS
Xemax Surgical Products Inc
D867CLEGS0
HIBCC
August 29, 2025
1
804495695 *Terms of Use
Etchant Gel is 37% phosphoric acid (H3PO4) polymer-thickened and intended for use on enamel to prepare the surface for bonding. 6.5 gm push syringe of gel etchant with 20 tips.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
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?
36153 Dental tooth-etching solution
An acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be reused.
Active false
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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 [?]
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

[?]
Storage and Handling
Special Storage Condition, Specify: Store at room temperature (15-30 Degrees C )
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
362b01e5-f523-4c75-83af-d326d431e378
October 09, 2025
5
May 22, 2017
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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

[?]
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

[?]
+0117072247817
customerservice@xemax.com
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