Identity
- Trade Name
- PATTERN RESIN™ LS FDA UDI
- Generic Name
- Dental acrylic resin FDA UDI
- Device Name
- PATTERN RESIN™ LS 1-1 Pack (1 x 100g powder, 1 x 105mL liquid, 2 x mixing cups, 1 x brush No. 4 & 1 x pipette) FDA UDI
- Model / Reference
- 335201 FDA UDI
- Description
- PATTERN RESIN™ LS 1-1 Pack (1 x 100g powder, 1 x 105mL liquid, 2 x mixing cups, 1 x brush No. 4 & 1 x pipette) FDA UDI
Identifiers
- Catalog Number
- 335201 FDA UDI
- Primary DI / UDI-DI
- 10386040000949 FDA UDI
- 510(k) Number
- K942670 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Dental acrylic resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental acrylic resin
Pattern Resin™ Ls by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental acrylic resin.
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Cleared under the same submission
K942670 also covers:
- PATTERN RESIN™ LS — Gc America Inc.
- PATTERN RESIN™ LS — Gc America Inc.
- PATTERN RESIN™ LS — Gc America Inc.
- PATTERN RESIN™ LS — Gc America Inc.
- PATTERN RESIN™ LS — Gc America Inc.
- PATTERN RESIN™ LS — Gc America Inc.
- PATTERN RESIN™ LS — Gc America Inc.
- PATTERN RESIN™ LS — Gc America Inc.
- PATTERN RESIN™ LS — Gc America Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gc America Inc.
Sources (1)
- FDA UDI f6403177-f690-44db-baf0-35f32cc4ef8d 36 fields · synced Jun 1, 2026