AccessGUDID - DEVICE: AdDent (D8691120010)

GUDID

Device Identifier (DI) Information

Brand Name: AdDent
Version or Model: OraBlu
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 112001
Company Name: ADDENT, INC.

Primary DI Number: D8691120010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 099490679 *Terms of Use

Device Description: The ORABLU Oral Lesion Marking System is a three component swab system intended to be used by a dentist or physician as an adjunct to traditional oral examination by incandescent light with further examination with an oral examination light manufactured by AdDent,Inc. The ORABLU Oral Lesion Marking System is used as an aid to enhance the visualization of oral mucosal irregularities by physically marking areas of oral mucosa that may warrant further investigation.

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?
43595	Toluidine blue O solution IVD	A toluidine blue O solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NXV	Diagnostic Light, Soft Tissue Detector

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121282	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: ecf634f9-3b2d-4275-b788-f7f1ff02dfd7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 01, 2017