AccessGUDID - DEVICE: EZ-Fill Xpress (00766054000167)

GUDID

Device Identifier (DI) Information

Brand Name: EZ-Fill Xpress
Version or Model: 1620-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1620-00
Company Name: ESSENTIAL DENTAL SYSTEMS, INC.

Primary DI Number: 00766054000167
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101147171 *Terms of Use

Device Description: Root Canal Xpress Cement Syringeable with Bi-Directional Spirals Stainless Steel

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?
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
KIF	RESIN, ROOT CANAL FILLING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063856	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 60 and 85 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Two - 9.5 gram dual barrel syringes

Device Record Status

Public Device Record Key: 411dd56a-6cd9-4490-9a65-48ec48ec844e
Public Version Date: November 22, 2023
Public Version Number: 4
DI Record Publish Date: July 01, 2016