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Plasdent

FDA UDI

Class I (US FDA UDI)

by Plasdent Corp.

Identity

Trade Name
Plasdent FDA UDI
Generic Name
Endodontic instrument-holding insert, single-use FDA UDI
Device Name
Square Endo Foam Inserts, Dark Gray FDA UDI
Model / Reference
EFI2-9X FDA UDI
Description
Square Endo Foam Inserts, Dark Gray FDA UDI

Identifiers

Catalog Number
EFI2-9X FDA UDI
Primary DI / UDI-DI
D832EFI29X1 FDA UDI
FDA Product Code
NAB FDA UDI
GMDN Term
Endodontic instrument-holding insert, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4014 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endodontic instrument-holding insert, single-use

Plasdent by Plasdent Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endodontic instrument-holding insert, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Plasdent Corp.

Sources (1)

  • FDA UDI 7233f223-5891-4402-a941-358b7e5842ce 34 fields · synced May 30, 2026