FDA UDI
In Commercial Distribution
🇺🇸 United States
Mini-Bowls
DI: D701BMM22
·
Model: B-MM2
·
PULPDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Mini-Bowls
- Primary DI
- D701BMM22
- Version / Model
- B-MM2
- Company Name
- PULPDENT CORPORATION
- Labeler DUNS
- 001006089
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2021-09-22
- Public Version
- 2
- Public Version Date
- 2023-05-04
- Public Version Status
- Update
- Public Device Record Key
- 28c475a7-1e47-4d9c-9699-bee39178ae9a
Device Description
Non-stick silicone for acrylics, with suction base. Medium, 30 cc (Set of 2) (1 5/8” diameter)
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 |
|---|---|---|---|---|
| JDZ | Mixer, Cement, For Clinical Use | Orthopedic | 888.4210 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63877 | Dental material mixing surface, chairside, reusable | A slab, tray, or well, or palette with wells intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patient, or extraorally to a dental restoration, during a dental procedure. It is typically made of plastic or glass and the user will ordinarily mix the component materials on or in the device by hand (e.g., with a spatula or brush). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D701BMM22 | HIBCC | ||||
| Unit of Use | D701BMM1 | HIBCC |