DEVICE: SIMPLANT® (07392532177286)

Device Identifier (DI) Information

SIMPLANT®
54500219
In Commercial Distribution

Dentsply Implants NV
07392532177286
GS1

1
764142159 *Terms of Use
Immediate Smile Complete
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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 crown/bridge, temporary A prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].
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FDA Product Code

[?]
Product Code Product Code Name
EBG CROWN AND BRIDGE, TEMPORARY, RESIN
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K113739 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Storage in the original packaging, in a dry place, at normal room temperature.
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Clinically Relevant Size

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

06163b0d-67f4-4efb-b5e9-ab6b5cb75439
July 06, 2018
3
March 16, 2016
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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
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)531-3481
implants-na-cs@dentsply.com
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