AccessGUDID - DEVICE: ROEKO Calcium Hydroxide PLUS Points (E1653668151)

GUDID

Device Identifier (DI) Information

Brand Name: ROEKO Calcium Hydroxide PLUS Points
Version or Model: ISO 15
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 366815
Company Name: Coltène/Whaledent GmbH + Co. KG

Primary DI Number: E1653668151
Issuing Agency: HIBCC
Commercial Distribution End Date: January 01, 2021
Device Count: 60
Labeler D-U-N-S® Number*: 315494443 *Terms of Use

Device Description: No description.

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:	Yes
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?
34791	Root canal obturating point	A metallic or polymeric based point or cone suitable for use in the obturation of the dental root-canal, but not for support of a coronal restoration.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

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

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
Special Storage Condition, Specify: keep dry
Storage Environment Temperature: less than 77 Degrees Fahrenheit
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: ISO 15

Device Record Status

Public Device Record Key: 0abe3913-750b-4b88-b58f-b418c7644fa7
Public Version Date: March 25, 2022
Public Version Number: 4
DI Record Publish Date: February 01, 2018