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MicroMega Paper Points

FDA UDI

Class I (US FDA UDI)

by Coltène/Whaledent AG

Identity

Trade Name
MicroMega Paper Points FDA UDI
Generic Name
Endodontic paper point FDA UDI
Device Name
MicroMega One RECI Paper Points 0.04 # 45 FDA UDI
Model / Reference
60031749 FDA UDI
Description
MicroMega One RECI Paper Points 0.04 # 45 FDA UDI

Identifiers

Catalog Number
60031749 FDA UDI
Primary DI / UDI-DI
E165600317492 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endodontic paper point

MicroMega Paper Points by Coltène/Whaledent AG — 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

Sources (1)

  • FDA UDI e9052286-0664-4554-b5d9-b8d33a08308c 36 fields · synced Jun 8, 2026