AccessGUDID - DEVICE: BISICO Cementime DC (EBIB037301)

GUDID

Device Identifier (DI) Information

Brand Name: BISICO Cementime DC
Version or Model: 03730
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03730
Company Name: bisico Bielefelder Dentalsilicone GmbH & Co. KG

Primary DI Number: EBIB037301
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316133664 *Terms of Use

Device Description: Dual-curing, semipermanent luting cement for crowns and bridges on dental implants

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?
16703	Ethoxy benzoic acid dental cement	A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between ethoxy benzoic acid (EBA) and zinc oxide (ZnO). It typically includes some additional fillers/components. 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 [?]
K091735	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
Storage Environment Temperature: less than 20 Degrees Celsius
Handling Environment Temperature: less than 20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 18e7a981-a865-4f6a-9fcd-ab43dd747335
Public Version Date: June 29, 2020
Public Version Number: 4
DI Record Publish Date: November 29, 2017