AccessGUDID - DEVICE: TEMP CANAL ENHANCED (D701TEK2)

GUDID

Device Identifier (DI) Information

Brand Name: TEMP CANAL ENHANCED
Version or Model: TEK
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PULPDENT CORPORATION

Primary DI Number: D701TEK2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001006089 *Terms of Use

Device Description: KIT: 3 mL SYRINGE +12 ENDO IRRIGATION NEEDLES -Calcium hydroxide canal treatment paste

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:	Yes
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?
38770	Dental pulp-capping material	A dental compound designed to cover an exposed or nearly-exposed dental pulp (e.g., due to deep cavities) to provide protection against external influences and to promote healing. This compound does not have dental cement or dental cavity liner intended uses. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EJK	Liner, Cavity, Calcium Hydroxide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120003	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
Total Volume: 3 Milliliter

Device Record Status

Public Device Record Key: 0986ec09-6a43-473f-ac20-7c4fcf364adb
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 08, 2016