FDA Registration
Active
🇮🇱 Israel
IRIS - Snap On
Reg #: 3007518363
·
FEI: 3007518363
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ADIN DENTAL IMPLANT SYSTEMS LTD.
- Registration Number
- 3007518363
- FEI Number
- 3007518363
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Alon Tavor Industrial Zone, POB 1128
- City
- Afula Northern
- Country
- IL
Owner / Operator
- Firm Name
- ADIN DENTAL IMPLANT SYSTEMS Ltd
- Operator Number
- 10028570
- Address
- Industrial Zone
- City
- Alon Tavor
- State
- Northern
- Postal Code
- 1811101
- Country
- IL
- Correspondent
- Ilana Lutvak
US Agent
- Business Name
- ADIN DENTAL SOLUTIONS USA, INC.
- Contact Name
- Ksenija Batistich
- Address
- 560 Sylvan Avenue, Suite 3160
- City
- Englewd Clfs
- State
- NJ
- ZIP
- 07632
- Country
- US
- [email protected]
- Phone
- 201 3742592
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2011-03-15 |
Proprietary Names
IRIS - Snap On
Open Tray Transfers, Close Tray Transfers, Screws for Transfers, Analogs, Replicas, Plastic Abutments, Casting Sleeve
Scan Bodies (7mm,, 10mm). TMA Scan Bodies (6mm, 9mm), TMA Scan body Screw
Guided surgery tools, fixture mounts, sockets, ratchet, extraction tool. screw drivers, depth probe, tissue punches
Guided Surgery Anchorage Screws, Sleeves
Guided Surgery CloseFit Tools
Drill stoppers. handles, hex tools, core tools, hex sample, centering ring, implant carrier, handles
Guided Surgery CloseFit Accessories Kit
Digital Analogs and Replicas
Guided surgery anchorage screw
Angled Trans Mucosal Abutment Gauge
Surgical Drivers, Angulated Drivers, Adapters, Parallel Pins, Depth Probe, Osteotome, Drill Extension, Ratchets, Wrench
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device