Identity
- Trade Name
- PowerMix™ Automatic Impression Material Dispenser FDA UDI
- Generic Name
- Dental material cartridge-plunging applicator, two-component, electric FDA UDI
- Device Name
- Two-component dental material applicator, electric FDA UDI
- Model / Reference
- 031121 FDA UDI
- Description
- Two-component dental material applicator, electric FDA UDI
Identifiers
- Catalog Number
- 031121 FDA UDI
- Primary DI / UDI-DI
- 00359883000608 FDA UDI
- FDA Product Code
- EFD FDA UDI
- GMDN Term
- Dental material cartridge-plunging applicator, two-component, electric 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 765 Gram FDA UDI
Category: Dental material cartridge-plunging applicator, two-component, electric
PowerMix™ Automatic Impression Material Dispenser by Den-Mat Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental material cartridge-plunging applicator, two-component, electric.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI f09543de-6758-44da-b1ed-45c92644f69f 37 fields · synced Jun 9, 2026