FDA UDI
In Commercial Distribution
🇺🇸 United States
Power Dental USA
DI: D94334080
·
Model: 3408
·
Power Dental U.S.A. Inc.
Product Codes
1
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Power Dental USA
- Primary DI
- D94334080
- Version / Model
- 3408
- Catalog Number
- 3408
- Company Name
- Power Dental U.S.A. Inc.
- Labeler DUNS
- 081305064
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-20
- Public Version
- 4
- Public Version Date
- 2024-10-21
- Public Version Status
- Update
- Public Device Record Key
- 54f1f5a7-4c6b-4af3-961d-a53b219c297e
Device Description
ENDO SPREADERS D11
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKR | PLUGGER, ROOT CANAL, ENDODONTIC | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35696 | Dental amalgam carrier | A hand-held dental instrument specially designed to collect, transport and deposit amalgam in its plastic state into prepared cavities. This is a reusable device. | No | Active |
| 38530 | Dental spatula, reusable | A hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device. | No | Active |
| 41876 | Endodontic plugger | A hand-held, manually-operated, dental instrument specifically designed to compress filling materials in a root canal, mainly in an axial direction. The working distal end is cylindrical or tapered, circular in cross-section, and has a flat-tipped end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D94334080 | HIBCC |
Customer Contacts
- Phone
- +1(815)363-8003
- [email protected]