DEVICE: Axcent Acrylics (D79338300080)
Device Identifier (DI) Information
Axcent Acrylics
3830008
In Commercial Distribution
3830008
GARRECO, LLC
3830008
In Commercial Distribution
3830008
GARRECO, LLC
ACR MON #3 SC (8 OZ EACH)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
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 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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBI | Resin, Denture, Relining, Repairing, Rebasing |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
dcf21156-3a00-41fb-ae91-1063f8f32194
March 29, 2018
2
September 25, 2016
March 29, 2018
2
September 25, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D79338300081 | 4 | D79338300080 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined