AccessGUDID - DEVICE: R-SI-LINE ® METAL-BITE ® Blue (ERDEMBK04751)

GUDID

Device Identifier (DI) Information

Brand Name: R-SI-LINE ® METAL-BITE ® Blue
Version or Model: MBK0475
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MBK0475
Company Name: R-Dental Dentalerzeugnisse GmbH

Primary DI Number: ERDEMBK04751
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 313956880 *Terms of Use

Device Description: METAL-BITE ® Blue is an universal and scannable registration material on vinyl polysiloxane base (addition curing, VPS). METAL-BITE ® Blue is extremely fast, hard and thixotropic. It is easy to trim, very suitable for cutting and contouring. The material has no taste at all, is radiopaque and offers an excellent dimension stability. Further on METAL-BITE ® Blue is predestined for static hicp and antagonist registrations, dynamic registrations according to FGP methods and classical facebow registrations. The registrations can then be scanned. METAL-BITE ® Blue was introduced with and for SIRONA CEREC systems (especially CEREC AC Bluecam) in early 2009. The Dental Advisor compared in its "Editors’ Note" METAL-BITE ® Blue with the classical METAL-BITE. METAL-BITE ® Blue is marketed worldwide. The product is available in standard 50 ml auto-mixing cartridges plus 12 mixing cannulas and can be dispensed with a commercial dispenser.

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:	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?
35866	Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELW	Material, Impression

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
Handling Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 22c2e495-41ac-4e60-85b8-ea3604aa42bc
Public Version Date: April 10, 2019
Public Version Number: 3
DI Record Publish Date: September 24, 2016