R-SI-LINE ® METAL-BITE ® - METAL-BITE ® is an universal registration - R-Dental Dentalerzeugnisse GmbH

Duns Number:313956880

Device Description: METAL-BITE ® is an universal registration material on vinyl polysiloxane base (addition cu METAL-BITE ® is an universal registration material on vinyl polysiloxane base (addition curing, VPS). METAL-BITE ® 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 ® is predestined for bite plate applications of the facebow registration system and for manufacturing surgical guides for implantology. It is used successfully for the fit of para-occlusal tray adapters in CMD. METAL-BITE ® was introduced in early 2000 and has earned several awards of excellence from Reality and The Dental Advisor from 2012 to 2016. METAL-BITE ® 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

MBK1074

Brand Name

R-SI-LINE ® METAL-BITE ®

Version/Model Number

MBK1074

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

98152b0f-aec2-43cd-8f99-10095f1f7e5c

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