AccessGUDID - DEVICE: Sodium Hypochlorite Solution (D6870011507FG2)

GUDID

Device Identifier (DI) Information

Brand Name: Sodium Hypochlorite Solution
Version or Model: 0011507FG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0011507FG
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D6870011507FG2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Sodium Hypochlorite Solution 16 oz.

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?
45500	Root canal cleaning solution	A fluid or gel material intended to be used in dentistry to facilitate cleaning/irrigation of the root canal during/after endodontic instrumentation to remove the smear layer, pulpal tissue, necrotic materials, and bacteria from the root canal, before placement of the endodontic filling; it may also act as a lubricant to facilitate the passage of an instrument (e.g., file/rasp) into the root canal. It is typically available as a disinfecting solution (e.g., chlorhexidine, sodium hypochlorite solution) delivered into the canal with an irrigation needle, or similar device, providing mechanical and possibly chemical cleaning of the canal. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KJJ	CLEANSER, ROOT CANAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 12 Bottles (16 oz/473mL)
Total Volume: 473 Milliliter

Device Record Status

Public Device Record Key: 77b20b0f-c693-42fe-9575-7a94eb2cd175
Public Version Date: May 06, 2020
Public Version Number: 4
DI Record Publish Date: September 21, 2016