AccessGUDID - DEVICE: Alpha-Ease® (D73540801010020)

GUDID

Device Identifier (DI) Information

Brand Name: Alpha-Ease®
Version or Model: 408.0101.002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 408.0101.002
Company Name: DENTAL TECHNOLOGIES, INC.

Primary DI Number: D73540801010020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 148312838 *Terms of Use

Device Description: Alpha-Ease® is a Hema/Gluteraldehyde desensitizer indicated for use on sensitive cavity preparations prior to the application of restorative material. It provides a physiological seal within the dentinal tubules by polymerization with the proteins in the tubules. The material provides virtually immediate relief from pain caused by hypersensitivity and is formulated with an antimicrobial to prevent microleakage. Kit Contains: 1 x 7ml Bottle

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?
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
KLE	Agent, Tooth Bonding, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K960365	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 2 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0f9c87ab-07ae-441a-acde-d6fc6413cc95
Public Version Date: February 07, 2019
Public Version Number: 4
DI Record Publish Date: September 23, 2016