FDA UDI
In Commercial Distribution
🇺🇸 United States
DiaTemp Flow
DI: 08806383565769
·
Model: Yellow Intro kit 0.5g
·
DiaDent Group International
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DiaTemp Flow
- Primary DI
- 08806383565769
- Version / Model
- Yellow Intro kit 0.5g
- Catalog Number
- A2001-6960
- Company Name
- DiaDent Group International
- Labeler DUNS
- 687789453
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-25
- Public Version
- 2
- Public Version Date
- 2021-10-29
- Public Version Status
- Update
- Public Device Record Key
- 73457125-cf8c-4b38-905e-3f7244750bc4
Device Description
DiaTemp Flow is a temporary fililng material that sets with curing light. In case that the cavity is not permanently restored, DiaTemp Flow can be used as a temporary restoration until the next appointment. DiaTemp Flow has four models and packaged with the syringe, disposable tip, protective cap.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | Dental | 872.3770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45236 | Temporary dental crown/bridge resin | A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08806383565769 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192022 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid expesure to direct sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius