AccessGUDID - DEVICE: STELLAR DC Acrylic (D8375050800)

GUDID

Device Identifier (DI) Information

Brand Name: STELLAR DC Acrylic
Version or Model: Splint Clear - Evaluator
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 50-5080
Company Name: Taub Products

Primary DI Number: D8375050800
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067488114 *Terms of Use

Device Description: STELLAR DC Acrylic is a dual cure acrylic that light cures in 20 seconds and self cures in 120 seconds. Used for repairing and relining clear splints.

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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63591	Dental acrylic resin	A non-sterile substance intended for professional use as a dental cement, luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, typically for short-term fixed prosthesis use (temporary crowns and bridges used for 6 months or less) or long-term removable prosthesis use. It consists of a self-, light-, or dual-curing acrylic resin material [e.g., polymethylmethacrylate (PMMA)]; it does not include any additional hardening fillers/components. It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKO	Denture Preformed (Partially Prefabricated Denture)
EBH	Material, Impression Tray, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Extremely light sensitive. Keep original cap on syringe directly before and after use. Keep away from heat. Refrigerate. See SDS.

Clinically Relevant Size

[?]

Size Type Text
Weight: 5.85 Gram

Device Record Status

Public Device Record Key: 160394b2-304f-4a31-867a-f5444190716e
Public Version Date: September 13, 2019
Public Version Number: 1
DI Record Publish Date: September 05, 2019