DEVICE: Axcent Acrylics (D79338300080)

Device Identifier (DI) Information

Axcent Acrylics
3830008
In Commercial Distribution
3830008
GARRECO, LLC
D79338300080
HIBCC

1
364004762 *Terms of Use
ACR MON #3 SC (8 OZ EACH)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
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
Dental appliance fabrication material, cured A resin that polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured) intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth); it may also be used to manufacture occlusal splints/night guards. It consists of a reactive component (e.g., acrylic monomer, reactive polymer) that undergoes polymerization (or vulcanization) to harden (with appropriate conditions/catalyst). Reinforcing fillers may be included in the resin to increase its strength and/or durability. After application, this material cannot be refabricated.
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FDA Product Code

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Product Code Product Code Name
EBI Resin, Denture, Relining, Repairing, Rebasing
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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

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

dcf21156-3a00-41fb-ae91-1063f8f32194
March 29, 2018
2
September 25, 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
D79338300081 4 D79338300080 In Commercial Distribution
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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
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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