Net Tray Premium Rotating for One Tooth

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 19397Model DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY

by Ydm Corporation

Identity

Trade Name: Net Tray Premium Rotating for One Tooth EUDAMED
NA FDA UDI
Generic Name: Dental impression tray, reusable FDA UDI
Device Name: Impression Tray EUDAMED
A horseshoe-shaped receptacle made of metal designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. FDA UDI
Model / Reference: DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
19397 EUDAMEDFDA UDI
Description: A horseshoe-shaped receptacle made of metal designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. FDA UDI

Identifiers

Catalog Number: 19397 FDA UDI
Primary DI / UDI-DI: 04963931193974 EUDAMEDFDA UDI
Basic UDI-DI: 4963931YDM00005WN EUDAMED
FDA Product Code: EHY FDA UDI
EMDN Code: Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
GMDN Term: Dental impression tray, reusable FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 872.6880 FDA UDI
Market of Registration: Spain EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Silicone dental impression material

Net Tray Premium Rotating for One Tooth by Ydm Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Silicone dental impression material.

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Bonasil A+ Regular (FS) 50ml x 32 — DMP Dental Industry S.A. · Class I
BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
Polysil Multipurpose Regular Set — Scican GmbH · Class II
PERFECTO — CROWN DELTA CORP. · Class II
Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I

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	4963931YDM00005WN	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Ydm Corporation
EUDAMED SRN: JP-MF-000011653
Authorised Representative: MedEnvoy Global BV NL-AR-000024028

Sources (2)

EUDAMED 18415af0-ea4e-4956-a36a-986c77108dda 61 fields · synced Jul 12, 2026
FDA UDI 07754b17-92d2-4fa8-ad16-feb651b1e5ee 35 fields · synced May 30, 2026