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3D Endo

FDA UDI

Class I (US FDA UDI)

by 3d Dental Designs And Development, Llc

Identity

Trade Name
3D Endo FDA UDI
Generic Name
Manual endodontic file/rasp, single-use FDA UDI
Device Name
Hedstrom Files NiTi 25mm #40 6/Pk FDA UDI
Model / Reference
HN2540 FDA UDI
Description
Hedstrom Files NiTi 25mm #40 6/Pk FDA UDI

Identifiers

Catalog Number
HN2540 FDA UDI
Primary DI / UDI-DI
00810126500540 FDA UDI
FDA Product Code
EKS FDA UDI
GMDN Term
Manual endodontic file/rasp, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Manual endodontic file/rasp, single-use

3D Endo by 3d Dental Designs And Development, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual endodontic file/rasp, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3d Dental Designs And Development, Llc

Sources (1)

  • FDA UDI 1414bae9-9f22-43af-99a6-7ffaf36d7d7b 34 fields · synced May 31, 2026