PHYSIOSTAR NFCplus

FDA UDI

Class II (US FDA UDI)

by Candulor AG

Identity

Trade Name: PHYSIOSTAR NFCplus FDA UDI
Generic Name: Resin artificial teeth FDA UDI
Model / Reference: 661478 FDA UDI

Identifiers

Catalog Number: 661478 FDA UDI
Primary DI / UDI-DI: E1996614781 FDA UDI
FDA Product Code: ELM FDA UDI
GMDN Term: Resin artificial teeth FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3590 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Resin artificial teeth

A comprehensive medical device for denture mounting, made of polymer-based material. The PhysioStar NFCplus is a pre-fabricated teeth set designed for dentures, ideal for patients with dental issues.

Similar devices

Also classified as Resin artificial teeth.

Resin Teeth / DCL / PE — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class II
Portrait® IPN® Anteriors — Dentsply International · Class II
artegral life — Merz Dental GmbH · Class II
Mondial 8i, D4 / M, CE — Kulzer, Inc. · Class II
Monarch — Wright Health Group , Ltd. · Class II
Ref-Line — POLIDENT d.o.o. · Class II
artegral life — Merz Dental GmbH · Class II
Resin Teeth DCL PE — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Candulor AG

Sources (1)

FDA UDI 2042dd4e-c3ee-4715-a999-a591de2c4b2f 33 fields · synced Jul 30, 2026