ParaPost Fiber White Intro Kit

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref PF160

by Coltene/Whaledent Inc.

Identity

Trade Name: ParaPost Fiber White Intro Kit EUDAMED
ParaPost Fiber White FDA UDI
Generic Name: Root canal post, preformed FDA UDI
Device Name: ParaPost Fiber White EUDAMED
ParaPost Fiber White One Office Visit Technique Introductory Kit Contents: 10 Fiber Posts, (3) #4.5, (3) #5, (2) #5.5, (2) #6 4 Drills, (1) #4.5, (1) #5, (1) #5.5, (1) #6 1 Universal Hand Driver FDA UDI
Model / Reference: PF160 EUDAMEDFDA UDI
Description: ParaPost Fiber White One Office Visit Technique Introductory Kit Contents: 10 Fiber Posts, (3) #4.5, (3) #5, (2) #5.5, (2) #6 4 Drills, (1) #4.5, (1) #5, (1) #5.5, (1) #6 1 Universal Hand Driver FDA UDI

Identifiers

Primary DI / UDI-DI: D661PF1601 EUDAMEDFDA UDI
Basic UDI-DI: B-D661PF1601 EUDAMED
FDA Product Code: ELR FDA UDI
EMDN Code: Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
GMDN Term: Root canal post, preformed FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 872.3810 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental appliance fabrication material, ceramic

ParaPost Fiber White Intro Kit by Coltene/Whaledent Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K000311	Class IIa	Active
EUDAMED	European Union	CE/MDD	B-D661PF1601	Class IIa	Active

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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 (3)

EUDAMED fb285b80-9b16-4b1a-a9e6-2a4d3e97949d 61 fields · synced Jul 10, 2026
FDA UDI afa2afc4-94a7-457a-bdfc-f25eb473030f 33 fields · synced May 29, 2026
FDA 510(k) K000311 1 fields · synced May 18, 2026