Identity
- Trade Name
- iFlex by TCS FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 5003-01B/CustomX10 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 5003-01B/CustomX10 FDA UDI
- Primary DI / UDI-DI
- D805500301BCUSTOMX10 FDA UDI
- 510(k) Number
- K123396 FDA UDI
- FDA Product Code
- MQC FDA UDIEBI FDA UDI
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
iFlex by TCS by Thermoplastic Comfort Sys — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K123396 also covers:
- iFlex by TCS — THERMOPLASTIC COMFORT SYS
- iFlex by TCS — THERMOPLASTIC COMFORT SYS
- iFlex by TCS — THERMOPLASTIC COMFORT SYS
- iFlex by TCS — THERMOPLASTIC COMFORT SYS
- iFlex by TCS — THERMOPLASTIC COMFORT SYS
- iFlex by TCS — THERMOPLASTIC COMFORT SYS
- iFlex by TCS — THERMOPLASTIC COMFORT SYS
- iFlex by TCS — THERMOPLASTIC COMFORT SYS
- iFlex by TCS — THERMOPLASTIC COMFORT SYS
- iFlex by TCS — THERMOPLASTIC COMFORT SYS
- iFlex by TCS — THERMOPLASTIC COMFORT SYS
- iFlex by TCS — THERMOPLASTIC COMFORT SYS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Thermoplastic Comfort Sys
Sources (1)
- FDA UDI 3449994b-2e46-4d33-90ca-d3f3036f4c01 36 fields · synced May 30, 2026