DEVICE: Stud-head screw titanium (EBRE450000560)

Device Identifier (DI) Information

Stud-head screw titanium
45000056
In Commercial Distribution
45000056
bredent GmbH & Co. KG
EBRE450000560
HIBCC

1
341086190 *Terms of Use
Stud-head screw titanium vks-oc/sg 1.7 exchangeable stud 1 Piece
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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?
38577 Bar dental precision attachment
A small shaft or splint typically made of austenitic alloys or alloys containing 75 percent or greater gold (Au) and metals of the platinum group, intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture. The device typically includes fixers (e.g., clasps, sleeves, or screws).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EGG ATTACHMENT, PRECISION, ALL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: keep dry
Special Storage Condition, Specify: keep out of sunlight
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

e37b080b-5a47-424d-bad7-d5720e1d9694
July 12, 2023
1
July 04, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
EBRE450000569 1 EBRE450000560 2023-07-04 Not in Commercial Distribution dummy
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+4907309872451
info@bredent.com
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