Identity
- Trade Name
- EXAlence™ FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- EXA’lence™ 370, Regular Set, 370mL Cartridge Standard Kit, Heavy Body (Dark Green), 1 x cartridge, 10 x Dynamic Mixing Tips, 1 x Bayonet Locking Ring FDA UDI
- Model / Reference
- 137270 FDA UDI
- Description
- EXA’lence™ 370, Regular Set, 370mL Cartridge Standard Kit, Heavy Body (Dark Green), 1 x cartridge, 10 x Dynamic Mixing Tips, 1 x Bayonet Locking Ring FDA UDI
Identifiers
- Catalog Number
- 137270 FDA UDI
- Primary DI / UDI-DI
- D6581372701 FDA UDI
- 510(k) Number
- K041398 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 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: Silicone dental impression material
EXAlence™ by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Silicone dental impression material.
- Defend — Young Innovations, Inc. · Class II
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- BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
- Polysil Multipurpose Regular Set — Scican GmbH · Class II
- PERFECTO — CROWN DELTA CORP. · Class II
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Cleared under the same submission
K041398 also covers:
- EXAlence™ — Gc America Inc.
- EXAlence™ — Gc America Inc.
- EXAlence™ — Gc America Inc.
- EXAlence™ — Gc America Inc.
- EXAlence™ — Gc America Inc.
- EXAlence™ — Gc America Inc.
- EXAlence™ — Gc America Inc.
- EXAlence™ — Gc America Inc.
- EXAlence™ — Gc America Inc.
- EXAlence™ — Gc America Inc.
- EXAlence™ — Gc America Inc.
- EXAlence™ — 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 d8c77701-181a-43ed-b980-9cb15d3a0c8a 37 fields · synced Jun 8, 2026