AccessGUDID - DEVICE: Apexit Plus (DVIV593991AN1)

GUDID

Device Identifier (DI) Information

Brand Name: Apexit Plus
Version or Model: 593991AN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 593991AN
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DVIV593991AN1
Issuing Agency: HIBCC
Commercial Distribution End Date: October 01, 2024
Device Count: 2
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: filling materials

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?
60510	Hygroscopic dental cement	A substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
EMA	CEMENT, DENTAL

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: c3b13673-7a5e-48be-9cce-b95bb2dacd79
Public Version Date: October 02, 2024
Public Version Number: 5
DI Record Publish Date: December 12, 2016