Identity
- Trade Name
- EXACLEAR FDA UDI
- Generic Name
- Polyether dental impression material FDA UDI
- Device Name
- EXACLEAR Translucent 2 VPS Cartridges (with 6 VPS Mixing Tips; size L; 48 mL). FDA UDI
- Model / Reference
- 008482 FDA UDI
- Description
- EXACLEAR Translucent 2 VPS Cartridges (with 6 VPS Mixing Tips; size L; 48 mL). FDA UDI
Identifiers
- Catalog Number
- 008482 FDA UDI
- Primary DI / UDI-DI
- D0470084821 FDA UDI
- 510(k) Number
- K933206 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Polyether 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
Dimensions & Sizes
- Size
- Total Volume — 48 Milliliter FDA UDI
Category: Polyether dental impression material
Exaclear by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyether dental impression material.
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- Ramitec™ — 3M Deutschland GmbH · Class I
- Impregum™ Penta™ Soft Medium Body — 3M Deutschland GmbH · Class II
- Impregum™ Penta™ — 3M Deutschland GmbH · Class II
- Impregum™ F — 3M Deutschland GmbH · Class II
Cleared under the same submission
K933206 also covers:
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 |
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Manufacturer
- Manufacturer
- Gc America Inc.
Sources (1)
- FDA UDI 6aedc4bf-9532-47ee-bdcd-9f2446dc7413 38 fields · synced Jun 8, 2026