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Essix C+®

FDA UDI

Class II (US FDA UDI)

by Dentsply Sirona Orthodontics Inc.

Identity

Trade Name
ESSIX C+® FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
Essix C+ plastic .040 square blue 25PK FDA UDI
Model / Reference
1C500-BL FDA UDI
Description
Essix C+ plastic .040 square blue 25PK FDA UDI

Identifiers

Catalog Number
1C500-BL FDA UDI
Primary DI / UDI-DI
D7461C500BL1 FDA UDI
FDA Product Code
NXC FDA UDI
EBG FDA UDI
KMY FDA UDI
MQC FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5470 FDA UDI
872.3770 FDA UDI
872.5525 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

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, thermoplastic

Essix C+® by Dentsply Sirona Orthodontics Inc. — 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
Dentsply Sirona Orthodontics Inc.

Sources (1)

  • FDA UDI bc51b618-cb1f-48cf-82b0-9efa6950e712 35 fields · synced Jun 9, 2026