FDA UDI
In Commercial Distribution
🇺🇸 United States
osseolink Implant
DI: 00816273020108
·
Model: IMP5013
·
OSSEOLINK USA LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- osseolink Implant
- Primary DI
- 00816273020108
- Version / Model
- IMP5013
- Company Name
- OSSEOLINK USA LLC
- Labeler DUNS
- 080083007
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-05
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- cbfe7c78-6fca-45df-8790-3d1423527747
Device Description
Implant 5.0mm x 13.0mm w Cover Screw
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
- MR Safe
- 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
- Yes
- Sterilization Methods
- Radiation 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 |
|---|---|---|---|---|
| 55848 | Screw endosteal dental implant, one-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 one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) 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 |
|---|---|---|---|---|---|---|
| Package | 10816273020105 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 00816273020108 | GS1 |
Customer Contacts
- Phone
- +1(877)677-3688
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091878 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Implant 5.0mm x 13.0mm w Cover Screw | ||
| Depth | 13 | Millimeter | |
| Width | 5 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight