← Back to catalogue

File-Rite™

FDA UDI

Class I (US FDA UDI)

by Pulpdent Corporation

Identity

Trade Name
FILE-RITE™ FDA UDI
Generic Name
Endodontic reaming aid material FDA UDI
Device Name
KIT: 4 x 5 gm syringes File-Rite + 50 applicator tips Canal Lubricant and Chelating Agent FDA UDI
Model / Reference
FILE FDA UDI
Description
KIT: 4 x 5 gm syringes File-Rite + 50 applicator tips Canal Lubricant and Chelating Agent FDA UDI

Identifiers

Primary DI / UDI-DI
D701FILE2 FDA UDI
FDA Product Code
EKL FDA UDI
GMDN Term
Endodontic reaming aid material FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3840 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endodontic reaming aid material

File-Rite™ by Pulpdent Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endodontic reaming aid material.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Pulpdent Corporation

Sources (1)

  • FDA UDI 7cf9075f-9046-4a9f-8622-ee306bb83f14 33 fields · synced Jun 9, 2026