AccessGUDID - DEVICE: EnaCem Z (EMICCPCZK1)

GUDID

Device Identifier (DI) Information

Brand Name: EnaCem Z
Version or Model: CPCZK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CPCZK
Company Name: MICERIUM SPA

Primary DI Number: EMICCPCZK1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436661136 *Terms of Use

Device Description: ENACEM Z KIT PRIMER + CEMENT 1 CPCZ ENACEM Z zirconia cement 8g. 1 CPCZP ENACEM Z Primer 5 ml.

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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
16704	Glass ionomer dental cement	A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMA	Cement, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062355	000

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
Handling Environment Temperature: between 3 and 11 Degrees Celsius
Special Storage Condition, Specify: Flammable

Clinically Relevant Size

[?]

Size Type Text
Weight: 8 Gram
Total Volume: 5 Milliliter

Device Record Status

Public Device Record Key: 514f8168-252a-4637-892d-8ed6a97998f7
Public Version Date: December 10, 2021
Public Version Number: 1
DI Record Publish Date: December 02, 2021