DEVICE: X-NAV, HANDPIECE CALIBRATION BIT LATCH, SZ-75 (D928P0112810)
Device Identifier (DI) Information
X-NAV, HANDPIECE CALIBRATION BIT LATCH, SZ-75
P011281
In Commercial Distribution
W.H. Holden, Inc.
P011281
In Commercial Distribution
W.H. Holden, Inc.
No description.
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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45320 | Dental drill bit extension |
A device intended to be attached to the shaft of a normal dental drill bit in order to lengthen it, providing greater accessibility and/or drilling capacity during a dental procedure. It is typically made of a high-grade metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DZA | Drill, Dental, Intraoral |
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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No Device Sizes |
Device Record Status
9d0e8cbf-f600-461b-8656-4d5188a8bba2
January 23, 2025
1
January 15, 2025
January 23, 2025
1
January 15, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
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
[?]
No Customer Contact currently defined