DEVICE: RevoCone Cap yellow, (EBRE430610080)
Device Identifier (DI) Information
RevoCone Cap yellow,
43061008
In Commercial Distribution
43061008
bredent GmbH & Co. KG
43061008
In Commercial Distribution
43061008
bredent GmbH & Co. KG
RevoCone Cap yellow, 8 N 4 pieces
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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 |
---|
No Device Sizes |
Device Record Status
ca2f399d-c13c-4702-ac6e-8cccc1fc3cbf
February 07, 2024
1
January 30, 2024
February 07, 2024
1
January 30, 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 |
---|---|---|---|---|---|
EBRE430610089 | 1 | EBRE430610080 | 2024-01-30 | 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:
No Unit of Use DI Numbers Found
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