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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
Endodontic obturation material distribution endpiece, single-use FDA UDI
Device Name
Finger Spreaders SS 25mm #45-80 6/Pk FDA UDI
Model / Reference
FS2545-80 FDA UDI
Description
Finger Spreaders SS 25mm #45-80 6/Pk FDA UDI

Identifiers

Catalog Number
FS2545-80 FDA UDI
Primary DI / UDI-DI
00810126500298 FDA UDI
FDA Product Code
EKK FDA UDI
GMDN Term
Endodontic obturation material distribution endpiece, 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endodontic obturation material distribution endpiece, 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 Endodontic obturation material distribution endpiece, 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 ff9cef1a-dde7-4ea4-9d9c-9c738ae0d8f9 35 fields · synced May 30, 2026