DEVICE: PRO Resins Arch X (04260635981525)
Device Identifier (DI) Information
PRO Resins Arch X
019.3260
In Commercial Distribution
019.3260
DeltaMed GmbH
019.3260
In Commercial Distribution
019.3260
DeltaMed GmbH
PRO Resins Arch X B1 1000g
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
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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? |
---|---|---|---|---|
62817 | Dental appliance fabrication material, combination-material |
A dental material made of a combination of metal, ceramic, and/or synthetic polymer [e.g., polyethylene (PE)] intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.
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Active | false |
16730 | Dental appliance fabrication material, resin |
A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.
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Active | false |
45236 | Temporary dental crown/bridge resin |
A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.
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Active | false |
38643 | Resin artificial teeth |
Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBF | Material, Tooth Shade, Resin |
EBI | Resin, Denture, Relining, Repairing, Rebasing |
EBG | Crown And Bridge, Temporary, Resin |
PZY | Additively Manufactured, Preformed, Resin Denture Tooth |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K243720 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: avoid direct sunlight |
Storage Environment Temperature: between 4 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c1dd949b-80bb-461f-872b-b492e7fcb8e3
February 24, 2025
1
February 14, 2025
February 24, 2025
1
February 14, 2025
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