AccessGUDID - DEVICE: R-SI-LINE ® METAL-BITE ® (ERDEMBK10741)

GUDID

Device Identifier (DI) Information

Brand Name: R-SI-LINE ® METAL-BITE ®
Version or Model: MBK1074
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MBK1074
Company Name: R-Dental Dentalerzeugnisse GmbH

Primary DI Number: ERDEMBK10741
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 313956880 *Terms of Use

Device Description: 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.

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: 98152b0f-aec2-43cd-8f99-10095f1f7e5c
Public Version Date: April 10, 2019
Public Version Number: 3
DI Record Publish Date: September 24, 2016