DEVICE: Bone Expander Screw Kit (00083208005558)
Device Identifier (DI) Information
Bone Expander Screw Kit
Bone Expander Screw Kit
In Commercial Distribution
Bone Expander Screw Kit (5)
Suncoast Dental, Inc
Bone Expander Screw Kit
In Commercial Distribution
Bone Expander Screw Kit (5)
Suncoast Dental, Inc
Bone Expander Screw Kit (5).
Contains 2.6, 3.0, 3.4, 3.8 and 4.3mm Expanders, Ratchet Wrench, Ratchet Extender, Latch Grip Adapter, Thumb Wrench, and Box
Used to create an osteotomy for Implant placement.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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55847 | Dental implant system |
A collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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DZN | Instruments, Dental Hand |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K141764 | 000 |
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
c580c722-31a7-4962-b000-2565063cbee4
May 31, 2021
2
February 03, 2021
May 31, 2021
2
February 03, 2021
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
[?]
(727) 536-4880
tatumcompliance@gmail.com
tatumcompliance@gmail.com