FDA UDI
In Commercial Distribution
🇺🇸 United States
Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 2.0g)
DI: 08806387896876
·
Model: 9687
·
Meta Biomed Co., Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 2.0g)
- Primary DI
- 08806387896876
- Version / Model
- 9687
- Company Name
- Meta Biomed Co., Ltd.
- Labeler DUNS
- 688322841
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-20
- Public Version
- 1
- Public Version Date
- 2022-09-28
- Public Version Status
- New
- Public Device Record Key
- 04e44761-8eaf-4af0-be46-2ea9a160a99e
Device Description
Renew-Cera is a coralline hydroxyapatite and a more active tricalcium phosphate bone grafting material for dental and craniofacial usage.It is comprised of 60% silicon substituted hydroxyapatite and 40% [3-tricalcium phosphate.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
| NPM | Bone Grafting Material, Animal Source | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47968 | Dental bone matrix implant, animal-derived | A sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) 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 used to fill bone cavities and defects and contains pores that 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 |
|---|---|---|---|---|---|---|
| Primary | 08806387896876 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080772 | 000 |