AccessGUDID - DEVICE: Alpha-Pro® White Varnish (D73540705010010)

GUDID

Device Identifier (DI) Information

Brand Name: Alpha-Pro® White Varnish
Version or Model: 407.0501.002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 407.0501.002
Company Name: DENTAL TECHNOLOGIES, INC.

Primary DI Number: D73540705010010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 148312838 *Terms of Use

Device Description: Alpha-Pro® White Varnish contains 5% sodium fluoride. It is used in the treatment of dental and post-operative sensitivity. Alpha-Pro White Varnish when applied practically becomes invisible, unlike traditional varnishes that cause unsightly yellow coloring of the teeth. Alpha-Pro White Varnish sets immediately on contact with saliva, leaving a smooth, thin layer. Kit Contains: 50 x 0.5ml Jars (Bubble Gum), 50 Applicator Brushes, Patient Instruction Pad, 50 "Keep Smiling" Stickers

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45232	Dental coating, tooth-desensitizing	A substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LBH	Varnish, Cavity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K124025	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
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bb4483f7-8b4b-48ee-a213-3ea087036f8e
Public Version Date: February 07, 2019
Public Version Number: 4
DI Record Publish Date: September 23, 2016