EZ-Fill Root Canal Cement

FDA UDI

Class II (US FDA UDI)

by Essential Dental Systems, Inc.

Identity

Trade Name: EZ-Fill Root Canal Cement FDA UDI
Generic Name: Hygroscopic dental cement FDA UDI
Device Name: Root Canal Cement Powder Jar/Gel Tube FDA UDI
Model / Reference: 1608-00 FDA UDI
Description: Root Canal Cement Powder Jar/Gel Tube FDA UDI

Identifiers

Catalog Number: 1608-00 FDA UDI
Primary DI / UDI-DI: 00766054000143 FDA UDI
510(k) Number: K992727 FDA UDI
FDA Product Code: KIF FDA UDI
GMDN Term: Hygroscopic dental cement FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hygroscopic dental cement

EZ-Fill Root Canal Cement by Essential Dental Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hygroscopic dental cement.

CeraPutty CP10 — Meta Biomed, Inc. · Class II
Avalon Biomed NeoSEALER Flo 2.2 g Refill Syringe — NUSMILE, LTD
AH Plus BioCermanic Sealer — TULSA DENTAL PRODUCTS LLC · Class II
MTA Flow — ULTRADENT PRODUCTS, INC. · Class II
MAARC DENTAL -Rootfyx — Shiva Products · Class II
Avalon Biomed NeoSEALER Flo Professional Kit 4.4 g - SAMPLE — NUSMILE, LTD
Avalon Biomed NeoSEALER Flo Professional Kit 4.4 g — NUSMILE, LTD
AH Plus BioCermanic Sealer — TULSA DENTAL PRODUCTS LLC · Class II

Cleared under the same submission

K992727 also covers:

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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Essential Dental Systems, Inc.

Sources (1)

FDA UDI 0b7922ca-0942-4ee6-bfe8-206cdebcfef7 38 fields · synced May 30, 2026