ParaPost XP Titanium - One-Office-Visit Introductory Kit

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref P780T

by Coltene/Whaledent Inc.

Identity

Trade Name: ParaPost XP Titanium - One-Office-Visit Introductory Kit EUDAMED
ParaPost XP FDA UDI
Generic Name: Pin/post dental drill bit FDA UDI
Device Name: ParaPost XP EUDAMED
ParaPost XP Intro Kit - Titanium FDA UDI
Model / Reference: P780T EUDAMEDFDA UDI
Description: ParaPost XP Intro Kit - Titanium FDA UDI

Identifiers

Primary DI / UDI-DI: D661P780T1 EUDAMEDFDA UDI
Basic UDI-DI: B-D661P780T1 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 XP Titanium - One-Office-Visit Introductory Kit by Coltene/Whaledent Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID

Similar devices

Also classified as Dental appliance fabrication material, ceramic.

Razor / MegaPlus — U&C International Co., Ltd · Class II
rainbow High shine — Genoss · Class II
Bloomden — Bloomden Bioceramics (Hunan) Co., Ltd. · Class II
Multi M Series — DMAX Co., Ltd. · Class II
Multi M Series — DMAX Co., Ltd. · Class II
BruxZir Shaded 16 PLUS — PRISMATIK DENTALCRAFT, INC. · Class II
CGI — CERAGROUP INDUSTRIES · Class II
ARENA Star — ARUM DENTISTRY Co., Ltd. · Class II

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-D661P780T1	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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

Manufacturer

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

Sources (2)

EUDAMED 6dd38035-2ea1-4493-a7d7-fd8600d209e0 61 fields · synced Jul 12, 2026
FDA UDI 9da15b11-d220-40c6-8a6a-880763b29992 33 fields · synced May 30, 2026