3D Dental

FDA UDI

Class I (US FDA UDI)

by 3d Dental Designs And Development, Llc

Identity

Trade Name: 3D Dental FDA UDI
Generic Name: Dental irrigation/aspiration syringe FDA UDI
Device Name: Endo Irrigation Syringes w/Needle Closed End 30ga 3cc 100/Pk FDA UDI
Model / Reference: EN30S FDA UDI
Description: Endo Irrigation Syringes w/Needle Closed End 30ga 3cc 100/Pk FDA UDI

Identifiers

Catalog Number: EN30S FDA UDI
Primary DI / UDI-DI: 00817169024378 FDA UDI
FDA Product Code: EIC FDA UDI
GMDN Term: Dental irrigation/aspiration syringe 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental irrigation/aspiration syringe

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: 3d Dental Designs And Development, Llc

Sources (1)

FDA UDI 87f87638-be2d-4875-8099-30b1309ca276 34 fields · synced Jun 8, 2026