DEVICE: Titanium screw M 1.4 x 3.5 mm (EBRE3300K7000)
Device Identifier (DI) Information
Titanium screw M 1.4 x 3.5 mm
3300K700
In Commercial Distribution
3300K700
bredent GmbH & Co. KG
3300K700
In Commercial Distribution
3300K700
bredent GmbH & Co. KG
Titanium screw M 1.4 x 3.5 mm 1 Piece
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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55849 | Screw endosteal dental implant, two-piece |
A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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EBL | PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 2.3 Millimeter |
Length: 5.5 Millimeter |
Device Record Status
878b5b42-44a4-47f2-8870-071be15d2cfd
March 29, 2018
2
September 22, 2016
March 29, 2018
2
September 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
EBRE3300K7009 | 1 | EBRE3300K7000 | 2016-09-22 | Not in Commercial Distribution | dummy |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
+4907309872451
info@bredent.com
info@bredent.com