FDA UDI
In Commercial Distribution
🇺🇸 United States
K3Pro Konus Dental Implants
DI: EAGNSK02K3PRO0
·
Model: SK02_K3Pro
·
Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- K3Pro Konus Dental Implants
- Primary DI
- EAGNSK02K3PRO0
- Version / Model
- SK02_K3Pro
- Catalog Number
- SK02_K3Pro
- Company Name
- Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG
- Labeler DUNS
- 312649568
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- d404ea23-f46a-4b4a-84ce-da5f49bc3659
Device Description
K3Pro Expert Tray Rapid & Sure
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44883 | Dental implant/prosthesis surgical procedure kit | A collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EAGNSK02K3PRO0 | HIBCC |
Customer Contacts
- Phone
- +49672130960
- [email protected]
- Phone
- +17158981434
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141159 | 000 |