FDA.reportPublic FDA data

iFlex by TCS

Primary DI
D805500301BCUSTOM5
Brand
iFlex by TCS
Company
THERMOPLASTIC COMFORT SYS
Model
5003-01B/ Custom-.5
Catalog number
5003-01B/ Custom-.5
Device 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.
Published
2023-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123396000I.FLEX BY TCSThermoplastic Comfort Systems, Inc.2013-01-10EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D805500301BCUSTOM5PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
562-426-2970info@tcsdentalinc.com

Regulatory Flags#

DUNS number
808897776
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D805500301BCUSTOMX100iFlex by TCS5003-01B/CustomX105003-01B/CustomX102025-01-22
D805500301BCUSTOMX10iFlex by TCS5003-01B/CustomX105003-01B/CustomX102024-03-11
D805200301B1X10Karadent by TCS2003-01B/1X102003-01B/1X102024-03-11
D805200301B25Karadent by TCS2003-01B/2-.52003-01B/2-.52024-03-11
D805200301B35Karadent by TCS2003-01B/3-.52003-01B/3-.52024-03-11
D805200301B3X5Karadent by TCS2003-01B/3X52003-01B/3X52024-03-11
D805200301B45Karadent by TCS2003-01B/4-.52003-01B/4-.52024-03-11
D805200301B4X5Karadent by TCS2003-01B/4X52003-01B/4X52024-03-11
D805200301BCUSTOM2Karadent by TCS2003-01/B Custom2003-01/B Custom2024-03-11
D805200301BNX10Karadent by TCS2003-01B/NX102003-01B/NX102024-03-11
D805200301BNX5Karadent by TCS2003-01B/NX52003-01B/NX52024-03-11
D805500301B1X10iFlex by TCS5003-01B/1X105003-01B/1X102024-03-11
D805500301B3X5iFlex by TCS5003-01B/3X55003-01B/3X52024-03-11
D805200001M12Karadent by TCS2000-01/M12000-01/M12023-11-06
D805200001S12Karadent by TCS2000-01/S12000-01/S12023-11-06
D805200301B12Karadent by TCS2003-01/B12003-01/B12023-11-06
D805200501L12Karadent by TCS2005-01/L12005-01/L12023-11-06
D805200501L2212Karadent by TCS2005-01/L22-12005-01/L22-12023-11-06
D805200501LF12Karadent by TCS2000-01/MF12000-01/MF12023-11-06
D805200501M2212Karadent by TCS2005-01/M22-12005-01/M22-12023-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07615208585773IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585780IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585797IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585803IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585810IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
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07615208585834IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585841IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
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04260670160527dentona flexisplintdentona AGMQC2026-06-23
04260670160534dentona flexisplintdentona AGMQC2026-06-23
04260670160541dentona flexisplintdentona AGMQC2026-06-23
04260670160558dentona flexisplintdentona AGMQC2026-06-23
04260670160572dentona flexisplintdentona AGMQC2026-06-23
04260670160589dentona flexisplintdentona AGMQC2026-06-23
04260670160596dentona vivatempdentona AGMQC2026-06-23
04260670160602dentona vivatempdentona AGMQC2026-06-23
04260670160619dentona vivatempdentona AGMQC2026-06-23
04260670160626dentona vivatempdentona AGMQC2026-06-23
04260670160633dentona vivatempdentona AGMQC2026-06-23
04260670160640dentona vivatempdentona AGMQC2026-06-23
04260670160657dentona vivatempdentona AGMQC2026-06-23
04260670160688optimill memosplintdentona AGMQC2026-06-23
04260670160695optimill memosplintdentona AGMQC2026-06-23
04260670160701optimill memosplintdentona AGMQC2026-06-23