DEVICE: ProTech Soft Reline (D814SRH12C1)
Device Identifier (DI) Information
ProTech Soft Reline
SRH12C
In Commercial Distribution
SRH12C
PROTECH PROFESSIONAL PRODUCTS INC
SRH12C
In Commercial Distribution
SRH12C
PROTECH PROFESSIONAL PRODUCTS INC
16 unit ProTech Soft Reline Heat Cure Kit Shade Clear - 220 gram powder, 120 ml monomer and 15 ml superbond
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]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. |
FDA Product Code
[?]Product Code | Product Code Name |
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EBI | Resin, Denture, Relining, Repairing, Rebasing |
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
a759c5ed-c0a4-41d6-a871-be5921f40ff0
March 29, 2018
2
August 30, 2016
March 29, 2018
2
August 30, 2016
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
[?]
No Customer Contact currently defined