FDA UDI
In Commercial Distribution
🇺🇸 United States
Micro Brush
DI: D798MBSF1
·
Model: MBSF
·
RELIANCE ORTHODONTIC PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- Micro Brush
- Primary DI
- D798MBSF1
- Version / Model
- MBSF
- Catalog Number
- MBSF
- Company Name
- RELIANCE ORTHODONTIC PRODUCTS INC
- Labeler DUNS
- 113170088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-08-05
- Public Version
- 3
- Public Version Date
- 2018-11-08
- Public Version Status
- Update
- Public Device Record Key
- 42b0dbc1-0fda-4899-b86e-b4ae3b6e0a9e
Device Description
Intended for use in the application of sealant resins or paste to enamel or aligners. This is the Super Fine version of the Microbrush.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| ECP | Instrument, Ligature Tucking, Orthodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35697 | Dental material application tool, single-use | A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D798MBSF1 | HIBCC | ||||
| Unit of Use | D798MBSF0 | HIBCC |
Customer Contacts
- Phone
- 630-773-4009
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at ambient conditions.