DEVICE: Tatum Surgical-Tapered Osteotome Kit (00083208033339)
Device Identifier (DI) Information
Tatum Surgical-Tapered Osteotome Kit
Tatum Tapered Straight Osteotome Kit
In Commercial Distribution
OsteotomeTapered Str 24
Suncoast Dental, Inc
Tatum Tapered Straight Osteotome Kit
In Commercial Distribution
OsteotomeTapered Str 24
Suncoast Dental, Inc
Tatum Tapered Straight Osteotome Kit designed for use in bone expansion utilizing Tatum Tapered & Integrity Implants: Includes 24 instruments and 2 Autoclaveable cassettes:
White - 3.0x15, 18, 21, 23, Blue - 3.5x12, 15, 18, & 21 Red - 4.0x12, 15, 18, & 21 Yellow - 4.5x12, 15, 18, & 21 Black - 5.0x12, 15, 18, & 21
Green - 6.0x12, 15, 18, & 21
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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44886 | Dental osteotome set |
A collection of dental surgical osteotomes used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. This device typically contains osteotomes of varying sizes and shapes and a surgical mallet or hammer. These are used for ridge expanding, bone condensing and sinus floor elevation procedures. This is a reusable device.
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FDA Product Code
[?]Product Code | Product Code Name |
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EMM | Chisel, Osteotome, Surgical |
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
af91eebd-2311-43e7-9ad1-1c7ae1e0b55c
August 12, 2020
1
August 04, 2020
August 12, 2020
1
August 04, 2020
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