ParaPost Taper Lux Intro Kit

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref PF180

by Coltene/Whaledent Inc.

Identity

Trade Name: ParaPost Taper Lux Intro Kit EUDAMED
ParaPost Fiber White FDA UDI
Generic Name: Pin/post dental drill bit FDA UDI
Device Name: ParaPost Taper Lux EUDAMED
ParaPost Fiber White Intro Kit FDA UDI
Model / Reference: PF180 EUDAMEDFDA UDI
Description: ParaPost Fiber White Intro Kit FDA UDI

Identifiers

Primary DI / UDI-DI: D661PF1801 EUDAMEDFDA UDI
Basic UDI-DI: B-D661PF1801 EUDAMED
FDA Product Code: DZA FDA UDI
EMDN Code: Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
GMDN Term: Pin/post dental drill bit FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 872.4130 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental appliance fabrication material, ceramic

ParaPost Taper Lux Intro Kit by Coltene/Whaledent Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-D661PF1801	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Coltene/Whaledent Inc.
EUDAMED SRN: US-MF-000015761
Authorised Representative: Coltène/Whaledent GmbH + Co. KG DE-AR-000005719

Sources (2)

EUDAMED e791ff88-9a6e-444f-8898-b0527e32a30d 61 fields · synced Jul 14, 2026
FDA UDI e0c1240e-a516-4b21-b947-9971b253d10e 33 fields · synced May 30, 2026