FDA Registration
Active
🇰🇷 South Korea
OSSVIS CO., LTD.
Reg #: 3025338240
·
FEI: 3025338240
·
Expires 2026
Products
12
Proprietary Names
149
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- OSSVIS CO., LTD.
- Registration Number
- 3025338240
- FEI Number
- 3025338240
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6F, 7F and B1, 38, Burim-ro 170beon-gil, Dongan-gu
- City
- Anyang-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K231079
Owner / Operator
- Firm Name
- Ossvis Co., Ltd.
- Operator Number
- 10086315
- Address
- 6F, 7F and B1, 38, Burim-ro 170beon-gil, Dongan-gu
- City
- Anyang-si
- State
- Gyeonggi
- Postal Code
- 14055
- Country
- KR
US Agent
- Business Name
- Withus Group Inc
- Contact Name
- April Lee
- Address
- 106 Superior
- City
- Irvine
- State
- CA
- ZIP
- 92620
- Country
- US
- [email protected]
- Phone
- 909 2749971
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2023-09-15 |
| Dental Implant Surgical Tray | OFY | Class 1 | Dental | No | 2023-05-24 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2023-03-29 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2023-03-03 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2023-03-03 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2023-08-09 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2023-03-03 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2023-03-29 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2022-10-30 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2023-03-03 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2023-03-29 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2023-03-29 |
Proprietary Names
LW Solid Abutment SET
LW Retraction Cap
LW Vis Abutment SET
Surgical Master Kit
Lili Guide Kit
Surgical Simple Kit 2
Sinus & GBR Kit
Lilivis Guide Full Kit
Surgical Option Kit
Surgical Simple Kit
Surgical Simple Kit 3
Surgical Master Kit2
OV Dental Mallet
LW UCLA Abutment
LW Pre-milled Abutment
LW Narrow Pre-milled Abutment
Guide Full Lindemann Drill
Bone Profile Drill
Diamond Reamer Drill
Step Drill
Crestal Drill
Stopper Point Drill
Lindemann Drill
Harvesting Drill
Guide Full Flattening Drill
Saw Disc
Guide Full Step Drill
Straight Round Bur
Guide Drill
Twist Drill S2
Cortical Drill
Guide Full lnitial Drill
Round Drill
Point Drill
Trimming Drill
Twist Drill
Guide Full Cortical Drill
LC Counter Sinking Drill
Path Drill
Short Cortical Drill
Short Step Drill
Cortical Drill S2
Short Twist Drill
Guide Full Twist Drill
Guide Full Anchor Twist Drill
OV Freer Elevator
LW Implant
LW Healing Abutment
LW Temporary Abutment
LW Implant System
LW Solid Abutment
LW Abutment Screw
LW Cover Screw
LW Angled Abutment
LW Vis Abutment
LW Implant SLA
OV Sinus Curette
Handle for tips
Guide Full Anchor Driver Engine
LW Digital Lab Analog GM
LW Plastic Impression Coping
Sinus Drill Stopper
LW Pick-up Impression Coping
LW Transfer Impression Coping
Bone Splitter 2
LW Scan Body SET
Bone Splitter 1
LW Narrow Transfer Impression Coping Guide Pin
LW Narrow Pick-up Impression Coping
1.2 Hex Driver Wrench
LW Pick-up Impression Coping Guide Pin
NoMount Driver Wrench
Torque Wrench
LW Oss Abutment Driver Engine
LW Narrow Scan Body Screw
LC NoMount Driver Wrench
LL Implant Driver Engine
1.2 Hex Driver Engine
LW Oss Abutment Transfer Impression Coping
LW Oss Abutment Transfer Impression Coping Guide Pin
LL Plastic Impression Coping
Parallel Pin
LW Scan Body Screw
LC Implant Path Pin
LC Transfer Impression Coping
LW Oss Abutment Driver Wrench
LW Scan Body
LC Transfer Impression Coping Guide Pin
Guide Full NoMount Driver Engine
LC Pick-up Impression Coping Guide Pin
LL Implant Driver Wrench
Guide Full Anchor Pin
Implant Path Pin
LW Narrow Scan Body
LW Oss Abutment Pick-up Impression Coping
LC NoMount Driver Engine
NoMount Driver Engine
LW Narrow Transfer Impression Coping
LW Mount Screw
Bone Tack Carrier
Bone Profile Guide Pin
LW Transfer Impression Coping Guide Pin
LC Pick-up Impression Coping
LW Narrow Pick-up Impression Coping Guide Pin
LW Lab Analog
Guide Full Anchor Driver Short Wrench
Drill Stopper
LW Mount
Drill Extension
LC Solid Abutment Plastic Impression Coping
Steel Bowl
Screw Remover Tip
LW Solid Lab Analog
LW Oss Abutment Clearance Gap Gauge
LW Oss Abutment Scan Body Screw
Drill Stopper S2
Wrench
LW Narrow Lab Analog
LL Lab Analog
Guide Full NoMount Driver Wrench
LW Oss Abutment Scan Body
LW Oss Abutment Pick-up Impression Coping Guide Pin
Bone Tack Case
1.2 Ball HEX Driver Wrench
LW Narrow Dirigal Lab Analog GM
LW Oss Slot Driver
LL Scan Body
LC Solid Plus Abutment Plastic Impression Coping
LL Driver Separator
Depth Gauge
OV Chisel
LL Mini Onebody Implant
LL Implant System
LL Temporary Cap
Convex Osteotome
LW Narrow Implant
LW Narrow Abutment Screw
LW Narrow Implant SLA
LW Narrow Solid Abutment
LW Narrow Angled Abutment
LW Narrow Vis Abutment
LW Narrow Temporary Abutment
LW Narrow UCLA Abutment
LW Narrow Vis Abutment SET
LW Narrow Cover Screw
LW Narrow Solid Abutment SET
LW Narrow Implant System
LW Narrow Healing Abutment
LW Implant System Abutment
Establishment Types
Manufacture Medical Device