Identity
- Trade Name
- Genie® Ultra Hydrophilic Impression Material FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- Genie® Impression Material Heavy Body Rapid Set - Berry Package FDA UDI
- Model / Reference
- 0077630FG FDA UDI
- Description
- Genie® Impression Material Heavy Body Rapid Set - Berry Package FDA UDI
Identifiers
- Catalog Number
- 0077630FG FDA UDI
- Primary DI / UDI-DI
- D6870077630FG1 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
Dimensions & Sizes
- Size
- Total Volume — 50 Milliliter FDA UDI
Category: Silicone dental impression material
Genie® Ultra Hydrophilic Impression Material by Dentsply International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Silicone dental impression material.
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- PERFECTO — CROWN DELTA CORP. · Class II
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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
- Dentsply International
Sources (1)
- FDA UDI 1599b11b-0803-424a-9ff5-0a3945e6fea5 37 fields · synced May 30, 2026