FDA UDI
In Commercial Distribution
🇺🇸 United States
BioRoot Flow-0.5 g
DI: 03701398102563
·
Model: 01E0500
·
SEPTODONT SAS SPECIALITES SEPTODONT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioRoot Flow-0.5 g
- Primary DI
- 03701398102563
- Version / Model
- 01E0500
- Catalog Number
- 01E0500
- Company Name
- SEPTODONT SAS SPECIALITES SEPTODONT
- Labeler DUNS
- 275273795
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-01
- Public Version
- 1
- Public Version Date
- 2022-02-09
- Public Version Status
- New
- Public Device Record Key
- 13b9f8b4-34fb-422c-a820-00f79113ab42
Device Description
Bioactive mineral Root Canal Sealer
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KIF | Resin, Root Canal Filling | Dental | 872.3820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60510 | Hygroscopic dental cement | A substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03701398102563 | GS1 |
Customer Contacts
- Phone
- 1-800-872-8305
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 86 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from Moisture