Identity
- Trade Name
- IH2 Fixture SLA FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x10.0mm, HEX 2.5mm FDA UDI
- Model / Reference
- AIH2FM3510SD FDA UDI
- Description
- SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x10.0mm, HEX 2.5mm FDA UDI
Identifiers
- Catalog Number
- AIH2FM3510SD FDA UDI
- Primary DI / UDI-DI
- 08800041301430 FDA UDI
- 510(k) Number
- K153521 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Screw endosteal dental implant, two-piece
IH2 Fixture SLA by sewon medix Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Screw endosteal dental implant, two-piece.
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- s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD · Class II
- ET II Fixture SA Mini No-Mounted — HIOSSEN INC. · Class II
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Cleared under the same submission
K153521 also covers:
- IH Angled Abutment — sewon medix Inc.
- IH Angled Abutment — sewon medix Inc.
- IH Cement Abutment — sewon medix Inc.
- IH Cement Abutment — sewon medix Inc.
- IH Cement Abutment — sewon medix Inc.
- IH Cement Abutment — sewon medix Inc.
- IH Cement Abutment — sewon medix Inc.
- IH Cement Abutment — sewon medix Inc.
- IH Cement Abutment — sewon medix Inc.
- XP-I SLA Fixture — sewon medix Inc.
- XP-I SLA Fixture — sewon medix Inc.
- XP-I SLA Fixture — sewon medix Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- sewon medix Inc.
Sources (2)
- FDA UDI 33b88e03-91c8-48fd-a26d-87b66bb7b5c0 36 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026