DEVICE: MPa™ Max Adhesive with Chlorhexidine Kit (07540172010788)

Device Identifier (DI) Information

MPa™ Max Adhesive with Chlorhexidine Kit
266901
In Commercial Distribution
266901
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
07540172010788
GS1

1
626406016 *Terms of Use
Dental Bonding Agent
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
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
Dentine bonding agent/set A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. 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
KXR APPLICATOR, RESIN
JEW TIP, RUBBER, ORAL HYGIENE
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

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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

0fb05a9a-ec3a-4e10-87de-c6196f5f440a
March 29, 2018
2
September 16, 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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)265-3444
info@clinicianschoice.com
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