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Essix

FDA UDI

Class I (US FDA UDI)

by Dentsply Sirona Orthodontics Inc.

Identity

Trade Name
Essix FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
Essix 3mm Dual Laminate Square PK/12 FDA UDI
Model / Reference
1MEDL FDA UDI
Description
Essix 3mm Dual Laminate Square PK/12 FDA UDI

Identifiers

Catalog Number
1MEDL FDA UDI
Primary DI / UDI-DI
D7461MEDL1 FDA UDI
FDA Product Code
KMY FDA UDI
NXC FDA UDI
EBG FDA UDI
MQC FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5525 FDA UDI
872.5470 FDA UDI
872.3770 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 by Dentsply Sirona Orthodontics Inc. — Class I — 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 4ed42b6f-72ec-42cc-81e6-935b702181d8 35 fields · synced Jun 9, 2026