Identity
- Trade Name
- Pink Silicast FDA UDI
- Generic Name
- Earmould impression material FDA UDI
- Device Name
- Pink Silicast Impression Material - two 335g tubs FDA UDI
- Model / Reference
- NA FDA UDI
- Description
- Pink Silicast Impression Material - two 335g tubs FDA UDI
Identifiers
- Catalog Number
- 10301 FDA UDI
- Primary DI / UDI-DI
- 00850047788177 FDA UDI
- FDA Product Code
- LDG FDA UDI
- GMDN Term
- Earmould impression material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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: Earmould impression material
Pink Silicast by Westone Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Earmould impression material.
- classic futur red 660g — DETAX GmbH · Class I
- PRO3DURE PR-1 — Pro3Dure Medical · Class I
- detax addition blue 2 x 5000 ml — DETAX GmbH · Class I
- addition mini Junior Standardpack — DETAX GmbH · Class I
- PRO3DURE L-1 — Pro3Dure Medical · Class I
- PRO3DURE PR-1 — Pro3Dure Medical · Class I
- direct mold rose-transparent 8x50 ml — DETAX GmbH · U
- addition yellow 2 x 660g — DETAX GmbH · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Westone Laboratories, Inc.
Sources (1)
- FDA UDI 091ea6fb-6fec-4718-88d7-829d448802d3 34 fields · synced Jun 1, 2026