FDA Registration
Active
🇮🇱 Israel
MIS Implants Technologies Ltd.
Reg #: 3004203816
·
FEI: 3004203816
·
Expires 2026
Products
8
Proprietary Names
22
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- MIS Implants Technologies Ltd.
- Registration Number
- 3004203816
- FEI Number
- 3004203816
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- BAR LEV INDUSTRIAL PARK P.O.BOX 7
- City
- BAR LEV INDUSTRIAL PARK Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K200102
Owner / Operator
- Firm Name
- DENTSPLY SIRONA INC
- Operator Number
- 2511302
- Address
- 221 WEST PHILADELPHIA ST., SUITE 60W
- City
- York
- State
- PA
- Postal Code
- 17401
- Country
- US
US Agent
- Business Name
- DENTSPLY SIRONA INC
- Contact Name
- Dan Eagar
- Address
- 13320 Ballantyne Corp Pl
- City
- Charlotte
- State
- NC
- ZIP
- 28277
- Country
- US
- [email protected]
- Phone
- 704 4926977
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2021-04-07 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2024-11-27 |
| Dental Abutment Design Software For Dental Laboratory | PNP | Class 2 | Dental | No | 2020-08-18 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 2003-07-15 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2017-11-02 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2001-10-23 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2017-11-02 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2026-02-09 |
Proprietary Names
Attachments
Precision Attachment
4BONE BCH
Connect abutment
Connect abutment free rotation temporary cylinder
Connect abutment healing cap
Connect abutment anti rotation temporary cylinder
Anti rotation cementing cap for connect abutment
Free rotation cementing cap for connect abutment
Orthodontic Anchor Screw
MIS C1 Narrow Platform Conical Connection Implant System
MIS C1 Wide Platform Conical Connection Abutments
BondBone
MIS Short Implants
C1
MIS V3 Conical Connection Dental Implant System
Coni Con Ti Base
Ti Base
MIS Internal Hex Dental Implant System
SEVEN MGuide
MIS DENTAL IMPLANT SYSTEM
Seven, M4, Lance Implants
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)