FDA UDI
In Commercial Distribution
🇺🇸 United States
OKTAGON BL NC Healing abutment, Ø 5.5mm GH 2.0 mm
DI: EDRS220701
·
Model: 22070
·
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- OKTAGON BL NC Healing abutment, Ø 5.5mm GH 2.0 mm
- Primary DI
- EDRS220701
- Version / Model
- 22070
- Catalog Number
- 22070
- Company Name
- Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 318034329
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-15
- Public Version
- 2
- Public Version Date
- 2019-02-14
- Public Version Status
- Update
- Public Device Record Key
- 9816917d-3ce7-466c-bd3c-4b8cdb75f640
Device Description
BL NC Healing abutment, Ø 5.5mm GH 2.0 mm for OKTAGON Dental Implant BL NC
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55849 | Screw endosteal dental implant, two-piece | A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EDRS220701 | HIBCC | ||||
| Previous | EDRS220709 | HIBCC |
Customer Contacts
- Phone
- +492173398000
- [email protected]