FDA UDI
In Commercial Distribution
🇺🇸 United States
BIODENTINE - 5 PACK
DI: 03760140703366
·
Model: 01C0605
·
SEPTODONT SAS SPECIALITES SEPTODONT
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BIODENTINE - 5 PACK
- Primary DI
- 03760140703366
- Version / Model
- 01C0605
- Catalog Number
- 01C0605
- Company Name
- SEPTODONT SAS SPECIALITES SEPTODONT
- Labeler DUNS
- 275273795
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 3
- Public Version Date
- 2023-06-13
- Public Version Status
- Update
- Public Device Record Key
- de74c29c-c608-41f9-8136-afd9e35dc0fe
Device Description
Bioactive dentin substitute
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
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | 872.3250 | 2 |
| 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 | 03760140703366 | GS1 |
Customer Contacts
- Phone
- (303) 665-7535
- [email protected]