FDA UDI
In Commercial Distribution
🇺🇸 United States
Dental Porous Morsels 2x1.5g
DI: 00813909010335
·
Model: EU0822
·
NOVABONE PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Dental Porous Morsels 2x1.5g
- Primary DI
- 00813909010335
- Version / Model
- EU0822
- Catalog Number
- EU0822
- Company Name
- NOVABONE PRODUCTS, LLC
- Labeler DUNS
- 828813290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2025-07-17
- Public Version
- 1
- Public Version Date
- 2025-07-25
- Public Version Status
- New
- Public Device Record Key
- feb72a56-d44d-4c84-a8d5-0eba1d1b1ae0
Device Description
Synthetic bone void filler for dental applications
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47971 | Dental bone matrix implant, synthetic | A sterile bioabsorbable device made of synthetic material implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is typically made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), sometimes bioactive glasses or bioabsorbable polymers, and used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00813909013756 | GS1 | ||||
| Primary | 00813909010335 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112428 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1.5 | Gram |