Identity
- Trade Name
- Waterpik Densco Condensaire Amalgam Condenser FDA UDI
- Generic Name
- Dental amalgam condenser, reusable FDA UDI
- Device Name
- Complete kit - includes instrument, tips, and tip holder FDA UDI
- Model / Reference
- 083117-000 FDA UDI
- Description
- Complete kit - includes instrument, tips, and tip holder FDA UDI
Identifiers
- Catalog Number
- 083117-000 FDA UDI
- Primary DI / UDI-DI
- D6860831170005 FDA UDI
- FDA Product Code
- EKG FDA UDI
- GMDN Term
- Dental amalgam condenser, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Waterpik Densco Condensaire Amalgam Condenser by Water Pik, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Water Pik, Inc.
Sources (1)
- FDA UDI ad8ab5f7-f84d-463f-9487-c26cdef159e1 36 fields · synced Jun 8, 2026