FDA UDI
In Commercial Distribution
🇺🇸 United States
BioHorizons
DI: 00847236018450
·
Model: STCP
·
BIOHORIZONS IMPLANT SYSTEMS, INC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioHorizons
- Primary DI
- 00847236018450
- Version / Model
- STCP
- Company Name
- BIOHORIZONS IMPLANT SYSTEMS, INC
- Labeler DUNS
- 967279910
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-04
- Public Version
- 1
- Public Version Date
- 2021-06-14
- Public Version Status
- New
- Public Device Record Key
- 8a678aae-c128-48b5-a07c-d6160cd9bb23
Device Description
Stabili-Teeth Convenience Pack
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
| DZE | Implant, Endosseous, Root-Form | Dental | 872.3640 | 2 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65059 | Dental implant kit | A collection of prefabricated dental devices and components, which includes a dental implant, intended to be used during dental surgery and laboratory procedures to create and implant the foundation of a reconstructed tooth. In addition to the dental implant, it includes a dental abutment(s) (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), and additional components to facilitate restoration (e.g., abutment analog, abutment impression cap). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847236018450 | GS1 |