Identity
- Trade Name
- XP-I SLA Fixture FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, single-use FDA UDI
- Device Name
- SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x7.0mm FDA UDI
- Model / Reference
- BIH2FR4007S FDA UDI
- Description
- SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x7.0mm FDA UDI
Identifiers
- Catalog Number
- BIH2FR4007S FDA UDI
- Primary DI / UDI-DI
- 08800041365548 FDA UDI
- 510(k) Number
- K153521 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Fixture/appliance dental drill bit, single-use 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
No
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: Fixture/appliance dental drill bit, single-use
XP-I SLA Fixture by sewon medix Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Fixture/appliance dental drill bit, single-use.
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- Gates Glidden Drills — TULSA DENTAL PRODUCTS LLC · Class I
- Screw Removal Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Driva™ Gold Series Drills — BIOMET 3I, LLC · Class I
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.
- IH2 Fixture SLA — sewon medix Inc.
- XP-I SLA Fixture — sewon medix Inc.
- XP-I SLA Fixture — sewon medix Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- sewon medix Inc.
Sources (1)
- FDA UDI 2a0f9948-416d-4fe9-9428-e74c756a470a 36 fields · synced May 30, 2026