DEVICE: breCAM.HIPC (EBRE540033980)
Device Identifier (DI) Information
breCAM.HIPC
54003398
In Commercial Distribution
54003398
bredent GmbH & Co. KG
54003398
In Commercial Distribution
54003398
bredent GmbH & Co. KG
breCAM.HIPC Ø 98.4 x 20mm bleach 1 Piece
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? |
---|---|---|---|---|
62817 | Dental appliance fabrication material, combination-material |
A dental material made of a combination of metal, ceramic, and/or synthetic polymer [e.g., polyethylene (PE)] intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ELM | Denture, plastic, teeth |
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 dry |
Special Storage Condition, Specify: keep out of sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Height: 20 Millimeter |
Outer Diameter: 98.4 Millimeter |
Device Record Status
4f6fb92d-1f69-406e-a773-c209cab8027b
September 25, 2023
1
September 15, 2023
September 25, 2023
1
September 15, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
EBRE540033989 | 1 | EBRE540033980 | 2023-09-15 | 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