AccessGUDID - DEVICE: ApexCal (DVIV598607AN1)

GUDID

Device Identifier (DI) Information

Brand Name: ApexCal
Version or Model: 598607AN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 598607AN
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DVIV598607AN1
Issuing Agency: HIBCC
Commercial Distribution End Date: August 25, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: ApexCal Refill 2.5 g

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?
60275	Endodontic temporary cement	A viscous material intended for the temporary obturation of a prepared root canal, to maintain relative sterility between procedures and facilitate healing. Commonly referred to as temporary filling or sealer, it is typically a zinc or calcium cement-based paste that includes an antimicrobial agent (e.g., pharmaceutical or pH), and sometimes an anti-inflammatory agent, available in a prefilled tube or syringe; some types require the use of a separate sealer. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 092092f9-7a49-47d2-a0a5-27f409c32036
Public Version Date: March 18, 2025
Public Version Number: 6
DI Record Publish Date: November 10, 2016