AccessGUDID - DEVICE: AuraLay XF Pit and Fissure Sealant (D820ALAYXFNT3ML0)

GUDID

Device Identifier (DI) Information

Brand Name: AuraLay XF Pit and Fissure Sealant
Version or Model: 3 mL Natural Translucent
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ALAYXFNT3
Company Name: DENALI CORPORATION

Primary DI Number: D820ALAYXFNT3ML0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 191036107 *Terms of Use

Device Description: Pit and Fissure Sealant

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):	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?
31780	Dental pit/fissure sealant	A resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EBC	Sealant, Pit And Fissure, And Conditioner

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071158	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: dbd6f788-71c7-4a72-a9ee-4b6b40b63679
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 05, 2016