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ProShape Paper Points F4

FDA UDI

Class I (US FDA UDI)

by Endo Direct, Llc

Identity

Trade Name
ProShape Paper Points F4 FDA UDI
Generic Name
Endodontic paper point FDA UDI
Model / Reference
PSPPF4 FDA UDI

Identifiers

Primary DI / UDI-DI
10810138822811 FDA UDI
FDA Product Code
EKN FDA UDI
GMDN Term
Endodontic paper point FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3830 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endodontic paper point

ProShape Paper Points F4 by Endo Direct, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endodontic paper point.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Endo Direct, Llc

Sources (1)

  • FDA UDI cc357535-aeff-42ac-bf65-130bae05a43e 32 fields · synced Jun 1, 2026