Identity
- Trade Name
- Power Dental USA FDA UDI
- Generic Name
- Dental amalgam carrier FDA UDI
- Device Name
- ENDO PLUGGERS/CONDENSERS RCA11.5A FDA UDI
- Model / Reference
- 3320 FDA UDI
- Description
- ENDO PLUGGERS/CONDENSERS RCA11.5A FDA UDI
Identifiers
- Catalog Number
- 3320 FDA UDI
- Primary DI / UDI-DI
- D9433320 FDA UDI
- FDA Product Code
- EKR FDA UDI
- GMDN Term
- Dental amalgam carrier FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental spatula, reusableEndodontic pluggerDental amalgam carrier
Power Dental USA by Power Dental USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Power Dental USA, Inc.
Sources (1)
- FDA UDI 264e59a5-e0c3-43e4-bb75-21dc38995367 35 fields · synced May 30, 2026