R-SI-LINE ® METAL-BITE ® Blue - METAL-BITE ® Blue is an universal and scannable - R-Dental Dentalerzeugnisse GmbH

Duns Number:313956880

Device Description: METAL-BITE ® Blue is an universal and scannable registration material on vinyl polysiloxan 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.

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More Product Details

Catalog Number

MBK0475

Brand Name

R-SI-LINE ® METAL-BITE ® Blue

Version/Model Number

MBK0475

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ELW

Product Code Name

Material, Impression

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"R-DENTAL DENTALERZEUGNISSE GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1