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Sign in to claim this brandWhat sewon medix Inc. makes
The company manufactures single-use dental drill bits for fixtures and appliances, as well as preformed permanent suprastructures for dental implants. It also produces reusable surgical screwdrivers and surgical procedure kits for dental implant and prosthesis placement, alongside two-piece screw endosteal dental implants.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does sewon medix Inc. manufacture?
sewon medix Inc. specializes in dental and surgical devices. Their portfolio includes single-use dental drill bits for fixtures and appliances, permanent preformed suprastructures for dental implants, reusable surgical screwdrivers, surgical procedure kits for dental implant and prosthesis placement, and two-piece screw endosteal dental implants. These devices cater to dental procedures and implantology.
Where is sewon medix Inc. based?
sewon medix Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and distribution within the US market.
Which regulatory registries list sewon medix Inc.’s devices?
All of sewon medix Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, regulators, and distributors, helping to verify device details and compliance.
How are sewon medix Inc.’s devices classified under FDA regulations?
sewon medix Inc.’s devices fall under Class I and Class II classifications under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines regulatory oversight and labeling requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- mydental.com
- —
- —
- [email protected]
- Phone
- +1-224-531-3099
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 688731065
Catalogue (94)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| XP-I SLA Fixture | AIH2FR3513S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | BIH2FR4508S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | BIH2FR4007S | FDA UDI | Class II | Active |
| IH Cement Abutment | AIHCARH5020S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | BIH2FR5011S | FDA UDI | Class II | Active |
| Screw Driver for Ratchet | RHD123L | FDA UDI | Class I | Active |
| XP-I SLA Fixture | BIH2FM3508S | FDA UDI | Class II | Active |
| IH Cement Abutment | AIHCARH4530M | FDA UDI | Class II | Active |
| XP-I SLA Fixture | BIH2FM3513S | FDA UDI | Class II | Active |
| IH Angled Abutment | AIHAARA503015 | FDA UDI | Class II | Active |
| IH Angled Abutment | AIHAAMA452015 | FDA UDI | Class II | Active |
| XP-I SLA Fixture | BIH2FR3515S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | AIH2FR4008S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | BIH2FR3507S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | AIH2FM3508S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | AIH2FR4511S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | BIH2FM3510S | FDA UDI | Class II | Active |
| IH Cement Abutment | AIHCAMH4520M | FDA UDI | Class II | Active |
| XP-I SLA Fixture | BIH2FR5008S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | AIH2FR5013S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | AIH2FR3507S | FDA UDI | Class II | Active |
| IH Cement Abutment | AIHCARH6025M | FDA UDI | Class II | Active |
| XP-I SLA Fixture | AIH2FM3510S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | BIH2FR4008S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | BIH2FR3511S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | AIH2FR4510S | FDA UDI | Class II | Active |
| IH2 Fixture SLA | AIH2FM3510SD | FDA UDI | Class II | Active |
| XP-I SLA Fixture | BIH2FR4011S | FDA UDI | Class II | Active |
| IH Cement Abutment | AIHCARH5020L | FDA UDI | Class II | Active |
| XP-I SLA Fixture | BIH2FR3508S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | BIH2FR4507S | FDA UDI | Class II | Active |
| IH Cement Abutment | AIHCARH5525M | FDA UDI | Class II | Active |
| XP-I SLA Fixture | AIH2FR4515S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | AIH2FR4007S | FDA UDI | Class II | Active |
| IH Screw Driver Ratchet | RIHD20L | FDA UDI | Class I | Active |
| IH Angled Abutment | AIHAAMA454025 | FDA UDI | Class II | Active |
| XP-I SLA Fixture | BIH2FR4515S | FDA UDI | Class II | Active |
| IH Cement Abutment | AIHCARH6040M | FDA UDI | Class II | Active |
| XP-I SLA Fixture | AIH2FR4011S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | BIH2FR4510S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | AIH2FR3511S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | BIH2FR4513S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | AIH2FR5007S | FDA UDI | Class II | Active |
| XP-I SLA Fixture | AIH2FR4013S | FDA UDI | Class II | Active |
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