AccessGUDID - DEVICE: QuickLine Varnish Base and Catalyst (10ml each) (00841549115974)

GUDID

Device Identifier (DI) Information

Brand Name: QuickLine Varnish Base and Catalyst (10ml each)
Version or Model: 220182
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STERNGOLD DENTAL LLC

Primary DI Number: 00841549115974
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124763728 *Terms of Use

Device Description: An acrylate-based light cured liquid material that when applied to polymerized composite surfaces, custom trays or temporary crown and bridges and light cured, produces a hard, gloss surface which is solvent and resistant. It also may be used as an oxygen barrier to pre-polymerized acrylic materials that after polymenization which will prevent a remaining oxygen inhibited layer. An additional use is to act as an acrylic condition when applied to acrylic upon receiving subsequent layer of acrylic to aid in adhesion of all acrylic materials involved.

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:	No
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62474	Dental prosthesis priming agent	A material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) and/or prosthesis component to promote bonding (e.g., to a composite resin cement, composite-based stain, or another prosthesis component). It may be referred to as a primer and includes compounds such as an unfilled-resin or silane-based agent; an applicator may also be included. The material is not intended to be used as a dentine bonding or dentine priming agent. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992609	000

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: b0e5a526-30c4-4a1a-bee9-2bdca7c54436
Public Version Date: August 01, 2025
Public Version Number: 4
DI Record Publish Date: July 18, 2023