Pindex System 12 Pindex Replacement Blades - 0.010

EUDAMEDFDA UDI

Class I (EU MDR)

Ref PX202

by Coltene/Whaledent Inc.

Identity

Trade Name: Pindex System 12 Pindex Replacement Blades - 0.010 EUDAMED
Pindex FDA UDI
Generic Name: Dental laboratory power tool system FDA UDI
Device Name: Pindex Model and Die Fabrication System EUDAMED
12 Pindex Replacement Blades - .010 FDA UDI
Model / Reference: PX202 EUDAMEDFDA UDI
Description: 12 Pindex Replacement Blades - .010 FDA UDI

Identifiers

Primary DI / UDI-DI: D661PX2021 EUDAMEDFDA UDI
Basic UDI-DI: ++D661019KN EUDAMED
FDA Product Code: NDP FDA UDI
EMDN Code: Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
GMDN Term: Dental laboratory power tool system FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 872.3980 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

Yes

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

Category: Dental appliance fabrication material, ceramic

Pindex System 12 Pindex Replacement Blades - 0.010 by Coltene/Whaledent Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	++D661019KN	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	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 cddbdeb3-f4e1-4c38-9892-1423e605ea82 61 fields · synced Jul 19, 2026
FDA UDI 1da2416a-b3d4-41f4-bf5d-18b211095df7 33 fields · synced May 30, 2026