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OneFill

FDA UDI

Class I (US FDA UDI)

by US Endodontics, LLC

Identity

Trade Name
OneFill FDA UDI
Generic Name
Warm-bonded endodontic obturation system obturator FDA UDI
Device Name
Endodontic Verifier FDA UDI
Model / Reference
704-0048 FDA UDI
Description
Endodontic Verifier FDA UDI

Identifiers

Catalog Number
704-0048 FDA UDI
Primary DI / UDI-DI
00810047644675 FDA UDI
FDA Product Code
EIL FDA UDI
GMDN Term
Warm-bonded endodontic obturation system obturator 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

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

Yes

FDA UDI

Category: Warm-bonded endodontic obturation system obturator

OneFill is a hand-held dental instrument designed for direct warm bonding during endodontic obturation procedures. It is preloaded with a resin-based sealing, filling, and core material at its distal working end which is subsequently heated in a dedicated oven to a specified temperature prior to delivery of the materials into a root canal.

Similar devices

Also classified as Warm-bonded endodontic obturation system obturator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
US Endodontics, LLC

Sources (1)

  • FDA UDI a9ce75f5-e2dc-4e30-8b2f-5bc60c5421ef 35 fields · synced Jul 22, 2026