AccessGUDID - DEVICE: EnaCem HF (EMICCPCK1)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: EMICCPCK1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436661136 *Terms of Use

Device Description: ENACEM HF+BONDING COMPLETE KIT 1 COS101 1 Ena Etch Orthophosphoric acid 37% 2ml 1 COSM101K CANULA 0,4 x 18mm. 1 COSM300A2 ENABOND Bonding Agent MONO 2ml 1 COSM300D-2 ENABOND Catalyst 2ml 5 COSM3A-1 ORANGE NEEDLETUBE 20 gauge 5 COSM3P-1 PLUG for NEEDLETUBE 20 gauge 1 CPC-3UD1 ENACEM HF DUAL CEMENT UD1 3g 1 CPC-3UD2 ENACEM HF DUAL CEMENT UD2 3g 1 CPC-3UD3 ENACEM HF DUAL CEMENT UD3 3g 1 CPC-3UD4 ENACEM HF DUAL CEMENT UD4 3g 5 CPCTIPL-1 White Syringe needle 8 CPCTIPN-1 AUTOMIX ENACEM needle 4 CPCTIPS-1 Intraoral Syringe Needle

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:	Yes
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?
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
63626	Dental prosthesis-component adhesive	A non-sterile adhesive material (e.g., self- or light-cured polymer composite) intended to be used to bond together components of a restorative dental prosthesis [e.g., crown, removable denture] by functioning as a glue between metal, synthetic, and/or ceramic materials; it is not intended to bond prosthetic devices to patient tissues (e.g., oral mucosa, teeth). Dedicated disposable devices associated with application [e.g., brush, mixing tip] may be included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMA	Cement, Dental
DYH	Adhesive, Bracket And Tooth Conditioner, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062355	000
K072978	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 2 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2c0e575a-2d55-4f05-8539-122fff2f2338
Public Version Date: December 10, 2021
Public Version Number: 1
DI Record Publish Date: December 02, 2021