AccessGUDID - DEVICE: Calcicur (E22110931)

GUDID

Device Identifier (DI) Information

Brand Name: Calcicur
Version or Model: 1093
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1093
Company Name: VOCO GmbH

Primary DI Number: E22110931
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316699578 *Terms of Use

Device Description: Calcicur is a radiopaque, ready-to-use water-based calcium hydroxide paste with a pH value of >12.5.

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?
62199	Calcium hydroxide dental cement	A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., pulp capping, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid (or related esters such as butan-1,3-diol disalicylate). It typically includes some additional fillers/components. After application, this device cannot be reused.	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
Storage Environment Temperature: between 15 and 23 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1fc31690-bbba-44c3-ad4c-987afe19b8b9
Public Version Date: June 13, 2019
Public Version Number: 1
DI Record Publish Date: June 05, 2019