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Color Tray Premium for Upper Pink
EUDAMEDFDA UDIClass I (EU MDR)
Ref 19101Model DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY
Identity
- Trade Name
- Color Tray Premium for Upper Pink EUDAMEDNA FDA UDI
- Generic Name
- Dental impression tray, reusable FDA UDI
- Device Name
- Impression Tray EUDAMEDA 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 EUDAMED19101 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
- 19101 FDA UDI
- Primary DI / UDI-DI
- 04963931191017 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
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Silicone dental impression material
Color Tray Premium for Upper Pink by Ydm Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Silicone dental impression material.
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- 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 35c4f608-5e26-450b-b72d-0f0685e18627 61 fields · synced Jun 17, 2026
- FDA UDI a910cc6f-9cdc-4d15-919e-12b22b469308 35 fields · synced May 30, 2026