Identity
- Trade Name
- PROMIX one FDA UDI
- Generic Name
- Dental amalgam mixer FDA UDI
- Device Name
- Dental mixer of Surefill one and Calibra Bio capsules, Brand Dentsply Sirona FDA UDI
- Model / Reference
- 2770001000 FDA UDI
- Description
- Dental mixer of Surefill one and Calibra Bio capsules, Brand Dentsply Sirona FDA UDI
Identifiers
- Catalog Number
- 2770001000 FDA UDI
- Primary DI / UDI-DI
- J00927700010000 FDA UDI
- FDA Product Code
- EFD FDA UDI
- GMDN Term
- Dental amalgam mixer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3100 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental amalgam mixer
PROMIX one by Renfert GmbH — 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
- Renfert GmbH
Sources (1)
- FDA UDI 2921d914-5088-422a-b00c-748cb7c92694 35 fields · synced May 30, 2026