Identity
- Trade Name
- Siltrax Plain 00 EUDAMEDSilTrax Plain Retraction Cord 7/00 FDA UDI
- Generic Name
- Gingival retraction cord, non-medicated FDA UDI
- Device Name
- Siltrax Plain EUDAMEDUntreated Braided Gingival Retraction Cord, 100 inches, Size: 7/00 FDA UDI
- Model / Reference
- 07397 EUDAMEDFDA UDI
- Description
- Untreated Braided Gingival Retraction Cord, 100 inches, Size: 7/00 FDA UDI
Identifiers
- Catalog Number
- 07397 FDA UDI
- Primary DI / UDI-DI
- 00310866000442 EUDAMEDFDA UDI
- Basic UDI-DI
- 03108662001FW EUDAMED
- FDA Product Code
- MVL FDA UDI
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
- GMDN Term
- Gingival retraction cord, non-medicated FDA UDI
Classification
- Device Class
- Class I EUDAMEDU FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gingival retraction cord, non-medicated
Siltrax Plain 00 by Pascal Company, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gingival retraction cord, non-medicated.
- Smartcord 2 — EASTDENT Co., Ltd · Class I
- roeko Retracto / braided / non-impregnated, x-fine (0), 225 cm — Coltène/Whaledent GmbH + Co. KG · Class I
- Hilo de retracción tejido Nº2 Dentaflux — J RIPOLL SL · Class I
- Hilo de retracción tejido Nº00 Dentaflux — J RIPOLL SL · Class I
- Henry Schein — HENRY SCHEIN, INC. · U
- roeko Stay-put / non-impregnated, x-fine (0), 183 cm — Coltène/Whaledent GmbH + Co. KG · Class I
- G-DENT Retraction Cord N.000 — UAB "Medicinos linija" · Class I
- Mouth Prop — Huanghua Promisee Dental Co.Ltd. · 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 | 03108662001FW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pascal Company Inc.
- EUDAMED SRN
- US-MF-000032036
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED f523e87c-1d83-4ff9-80b9-c6ad9b2be26d 61 fields · synced Jul 27, 2026
- FDA UDI 1d13187f-eda3-4f4c-93b6-45d00ca68be8 36 fields · synced May 30, 2026