FDA UDI
In Commercial Distribution
🇺🇸 United States
PowerMix™ Automatic Impression Material Dispenser
DI: 00359883000608
·
Model: 031121
·
DEN-MAT HOLDINGS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PowerMix™ Automatic Impression Material Dispenser
- Primary DI
- 00359883000608
- Version / Model
- 031121
- Catalog Number
- 031121
- Company Name
- DEN-MAT HOLDINGS, LLC
- Labeler DUNS
- 809857704
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-12
- Public Version
- 1
- Public Version Date
- 2025-03-20
- Public Version Status
- New
- Public Device Record Key
- f09543de-6758-44da-b1ed-45c92644f69f
Device Description
Two-component dental material applicator, electric
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFD | AMALGAMATOR, DENTAL, AC-POWERED | Dental | 872.3100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62681 | Dental material cartridge-plunging applicator, two-component, electric | An electrically-powered device intended to dispense a two-component dental material (e.g., impression material) [not included] from a cartridge directly into the mouth or into another device (e.g., impression tray). It is a handpiece with an electric cartridge-plunging mechanism; typically, a dental material mixing nozzle is attached to the distal tip of the cartridge during use. This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00359883000608 | GS1 |
Customer Contacts
- Phone
- +1(800)433-6628
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 765 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius