DEVICE: iFlex by TCS (D805500501M22N2)
Device Identifier (DI) Information
iFlex by TCS
5005-01/M22-N
In Commercial Distribution
5005-01/M22-N
THERMOPLASTIC COMFORT SYS
5005-01/M22-N
In Commercial Distribution
5005-01/M22-N
THERMOPLASTIC COMFORT SYS
iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates for removable dental prosthetic appliances. This includes but is not to be limited to full and partial removable dentures, orthodontics devices, occlusal splints, and night guards.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
58288 | Dental appliance fabrication material, thermoplastic |
A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQC | Mouthguard, Prescription |
EBI | Resin, Denture, Relining, Repairing, Rebasing |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K123396 | 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
35ae89a1-178a-48d6-a6e0-d5b0363e4c01
July 06, 2018
3
August 01, 2016
July 06, 2018
3
August 01, 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 |
---|---|---|---|---|---|
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:
D805500501M22N0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
562-426-2970
info@tcsdentalinc.com
info@tcsdentalinc.com