Pindex Laser Pinning System, 115V

EUDAMEDFDA UDI

Class I (EU MDR)

Ref PX113L

by Coltene/Whaledent Inc.

Identity

Trade Name: Pindex Laser Pinning System, 115V EUDAMED
Pindex FDA UDI
Generic Name: Dental laboratory power tool system FDA UDI
Device Name: Pindex Model and Die Fabrication System EUDAMED
Pindex Laser System, 115V FDA UDI
Model / Reference: PX113L EUDAMEDFDA UDI
Description: Pindex Laser System, 115V FDA UDI

Identifiers

Primary DI / UDI-DI: D661PX113L0 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
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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental appliance fabrication material, ceramic

Pindex Laser Pinning System, 115V by Coltene/Whaledent Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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/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

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 22fd473c-8d26-4d0a-a84c-b505a20555f9 61 fields · synced Jul 15, 2026
FDA UDI 00785496-a2d1-4359-9e5d-0b785888f779 33 fields · synced May 30, 2026