DEVICE: Blossom (D72DT4011TI0)

Device Identifier (DI) Information

Blossom
DT4011TI
In Commercial Distribution
DT4011TI
INTRA-LOCK INTERNATIONAL, INC.
D72DT4011TI0
HIBCC

1
131500998 *Terms of Use
Standard Platform, Ø4.0mm x 11.5mm DT Implant, 2mm Collar
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
DZE Implant, Endosseous, Root-Form
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K103194 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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

fee655e1-7482-4dd0-8038-e84c20202068
July 06, 2018
3
February 06, 2017
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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

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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
Yes
No
No CLOSE

Customer Contact

[?]
8773300338
info@intra-lock.com
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