DEVICE: NA (07630031736734)

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Device Record History
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Device Identifier (DI) Information
NA
surgically Invasive Instruments
Not in Commercial Distribution
066.0504S
Institut Straumann AG
07630031736734
GS1
July 03, 2024
1
483599259 *Terms of Use
BLX Drill 4, long, Ø 3.5mm, L 35mm, TAN
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
45714 Fixture/appliance dental drill bit, reusable
A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NDP Accessories, implant, dental, endosseous
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
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Clinically Relevant Size

[?]
Size Type Text
Length: 35 Millimeter
Outer Diameter: 3.5 Millimeter
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Device Record Status
2d53d758-9327-420e-acf8-44e4f659ccc2
June 16, 2025
3
December 02, 2022
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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
No Package DIs found
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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
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)448-8168
info.usa@straumann.com
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