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EZ-Fill Bi-Directional Spiral

FDA UDI

Class I (US FDA UDI)

by Essential Dental Systems, Inc.

Identity

Trade Name
EZ-Fill Bi-Directional Spiral FDA UDI
Generic Name
Manual endodontic filling material spreader FDA UDI
Device Name
EZ-Fill Bi-Directional Spiral 21mm Nickel Titanium FDA UDI
Model / Reference
1605-21 FDA UDI
Description
EZ-Fill Bi-Directional Spiral 21mm Nickel Titanium FDA UDI

Identifiers

Catalog Number
1605-21 FDA UDI
Primary DI / UDI-DI
00766054000280 FDA UDI
FDA Product Code
DZA FDA UDI
GMDN Term
Manual endodontic filling material spreader FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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 filling material spreader

EZ-Fill Bi-Directional Spiral by Essential Dental Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual endodontic filling material spreader.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Essential Dental Systems, Inc.

Sources (1)

  • FDA UDI 9509631a-8873-48ef-94d0-3a9a0a719b06 35 fields · synced Jun 1, 2026