DEVICE: CERALOG® PL Removal Tool 28mm (07640161397286)
Device Identifier (DI) Information
CERALOG® PL Removal Tool 28mm
HP5900.2040
In Commercial Distribution
HP5900.2040
CeramTec Schweiz GmbH
HP5900.2040
In Commercial Distribution
HP5900.2040
CeramTec Schweiz GmbH
Tools
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? |
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45319 | Dental implant extractor |
A manually-operated, one-piece dental device intended to be used to retrieve an in situ dental implant [i.e., anchorage and/or retention (abutment) component], typically because of damage (e.g., a broken collar) or malfunction, from the oral cavity. It typically has a cylindrical design and a cavity or threaded shaft at the working distal end intended to grip or be inserted into the implant. It may have a handle at the proximal end or be used in conjunction with a drill and/or a separate handle or wrench (not included); it is not a collection of devices (i.e., not a kit). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NDP | Accessories, implant, dental, endosseous |
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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Storage Environment Temperature: between 15 and 25 Degrees Celsius |
Special Storage Condition, Specify: Keep dry, Keep out of sunlight |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
61b82d4d-f861-4dcb-80bf-ef3bf4d61088
February 25, 2025
3
April 29, 2024
February 25, 2025
3
April 29, 2024
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
[?]
+41443883636
mpd.regulatory@ceramtec.de
mpd.regulatory@ceramtec.de