DEVICE: Prettau® 2 Dispersive® C1 1 (D800ZRKC0101C01)
Device Identifier (DI) Information
Prettau® 2 Dispersive® C1 1
ZRKC0101C01
In Commercial Distribution
ZIRKONZAHN SRL
ZRKC0101C01
In Commercial Distribution
ZIRKONZAHN SRL
Content: 1 piece, Height: 16 mm, Zirconia with natural colour gradient for single crowns up to large-span bridges (full contour restorations or reduced structures for ceramic layering)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
38615 | Dental bridge, ceramic |
A custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of ceramic/porcelain material and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EIH | Powder, Porcelain |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
07ba87a5-6cb9-4181-bcc1-d06d1d84890e
May 14, 2019
1
May 06, 2019
May 14, 2019
1
May 06, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+390474066660
info@zirkonzahn.com
info@zirkonzahn.com