AccessGUDID - DEVICE: Axcent Acrylics (D79338300080)

GUDID

Device Identifier (DI) Information

Brand Name: Axcent Acrylics
Version or Model: 3830008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3830008
Company Name: GARRECO, LLC

Primary DI Number: D79338300080
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 364004762 *Terms of Use

Device Description: ACR MON #3 SC (8 OZ EACH)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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

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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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dcf21156-3a00-41fb-ae91-1063f8f32194
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 25, 2016