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T-Crystal cartridges Clear

FDA UDI

Class II (US FDA UDI)

by Perflex

Identity

Trade Name
T-Crystal cartridges Clear FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
Box of 6 identical cartridges sealed in aluminum vacuum bag ; cartridge dimensions : 25mm diameter ; 107mm long ; each cartridge filled with 31Gr of T-Crystal Clear Thermoplastic pellets. FDA UDI
Model / Reference
25mm Diam. Extra Large 107mm long FDA UDI
Description
Box of 6 identical cartridges sealed in aluminum vacuum bag ; cartridge dimensions : 25mm diameter ; 107mm long ; each cartridge filled with 31Gr of T-Crystal Clear Thermoplastic pellets. FDA UDI

Identifiers

Catalog Number
112507 FDA UDI
Primary DI / UDI-DI
07290110500177 FDA UDI
FDA Product Code
EBI FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3760 FDA UDI
Commercial Distribution
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

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental appliance fabrication material, thermoplastic

T-Crystal cartridges Clear by Perflex — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, thermoplastic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Perflex

Sources (1)

  • FDA UDI 8ec241f1-8ee7-4db1-8446-fa88d40434cf 34 fields · synced May 30, 2026