DEVICE: Vario-Soft-Steg vss (EBRE430052600)
Device Identifier (DI) Information
Vario-Soft-Steg vss
43005260
In Commercial Distribution
43005260
bredent GmbH & Co. KG
43005260
In Commercial Distribution
43005260
bredent GmbH & Co. KG
Vario-Soft-Steg vss Matrices, yellow 8 pieces
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
38603 | Resilient dental precision attachment |
A dental fixation device designed to give a tooth-borne/tissue-borne prosthesis sufficient mechanical play to withstand the variations in the seating of the prosthesis due to deformation of the underlying tissues, without placing excessive stress on the abutments.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EGG | ATTACHMENT, PRECISION, ALL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: keep out of sunlight |
Special Storage Condition, Specify: keep dry |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 6.7 Millimeter |
Width: 3.4 Millimeter |
Height: 8.0 Millimeter |
Device Record Status
3ba64440-2b1c-4692-a695-8a046f8339c8
January 17, 2024
1
January 09, 2024
January 17, 2024
1
January 09, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
EBRE430052609 | 1 | EBRE430052600 | 2024-01-09 | Not in Commercial Distribution | dummy |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
EBRE430052608
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4907309872531
regulatory-affairs@bredent.com +4907309872451
info@bredent.com
regulatory-affairs@bredent.com +4907309872451
info@bredent.com