DEVICE: Tatum D Implant Kit (00083208611117)

Device Identifier (DI) Information

Tatum D Implant Kit
D Implant Kit
In Commercial Distribution
Tatum D Implant Kit
Suncoast Dental, Inc
00083208611117
GS1

1
078352849 *Terms of Use
Tatum D Implant Kit : A kit designed for simplicity and ease of use in placing Tatum D Implants: Kit Includes: Channel Formers D1, D2, D3, & D4. Socket Formers set of 3 each D1, D2, D3, & D4. Straight Seating Tool. Scalpel Handle. Post Guide PG.0, 10, 20, 30. Autoclaveable Cassette/Container for all pieces
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
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?
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.
Active true
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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

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ec5017d6-0974-4bd1-95bb-65102c11201e
August 10, 2020
1
July 31, 2020
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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
No
No
No CLOSE

Customer Contact

[?]
727-536-4880
tatumcompliance@gmail.com
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