DEVICE: ProTech Plus Hard Reline and Repair Acrylic (D814PLU12A1)
Device Identifier (DI) Information
ProTech Plus Hard Reline and Repair Acrylic
PLU12A
Not in Commercial Distribution
PLU12A
PROTECH PROFESSIONAL PRODUCTS INC
PLU12A
Not in Commercial Distribution
PLU12A
PROTECH PROFESSIONAL PRODUCTS INC
ProTech Plus Hard Reline and Repair Acrylic Kit - 440 gram powder shade 1069LO and 240 ml Monomer
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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? |
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34769 | Denture reliner, elastic, short-term |
A denture relining material intended to be applied by a dentist or dental laboratory technician as a temporary coating or lining on the base or tissue-contact surface of a denture and which has elastic properties after setting. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBI | Resin, Denture, Relining, Repairing, Rebasing |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K151646 | 000 |
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
50af9828-d1c4-4557-b05a-4f03fa0eee7d
May 20, 2019
5
August 29, 2016
May 20, 2019
5
August 29, 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