DEVICE: ProTech Soft Reline (D814SRC12C1)

Device Identifier (DI) Information

ProTech Soft Reline
SRC12C
In Commercial Distribution
SRC12C
PROTECH PROFESSIONAL PRODUCTS INC
D814SRC12C1
HIBCC

1
117374900 *Terms of Use
16 unit ProTech Soft Reline Self Cure Kit Shade Clear - 220 gram powder, 120 ml monomer and 15 ml superbond
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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No
Yes
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No

GMDN

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

GMDN Preferred Term Name GMDN Definition
Denture reliner, elastic, short-term A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a coating or lining on the base or tissue-contacting surface of a denture and which has elastic properties after setting and is intended for short-term use. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
EBI Resin, Denture, Relining, Repairing, Rebasing
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0eca96f9-b025-4c66-9b8e-472e9eebfae5
March 29, 2018
2
August 30, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
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Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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