Identity
- Trade Name
- INNO SLA Sub. Mount-Free Fixture FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Model / Reference
- ST3508SM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809471720002 FDA UDI
- 510(k) Number
- K132242 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
INNO SLA Sub. Mount-Free Fixture by Cowellmedi Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Screw endosteal dental implant, two-piece.
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- LW Vis Abutment — Ossvis Co., Ltd. · Class II
- s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD · Class II
- ET II Fixture SA Mini No-Mounted — HIOSSEN INC. · Class II
- LW Vis Abutment — Ossvis Co., Ltd. · Class II
- PRAMA RF WHITE IMPLANT ZIRTI — SWEDEN & MARTINA INC · Class II
Cleared under the same submission
K132242 also covers:
- INNO Implant System-Ball Abutment — Cowellmedi Co., Ltd
- INNO Implant System-Ball Abutment — Cowellmedi Co., Ltd
- INNO SLA Submerged Implant System-Temporary Abutment — Cowellmedi Co., Ltd
- INNO SLA Submerged Implant System-Temporary Abutment — Cowellmedi Co., Ltd
- INNO Submerged Implant System-Absolute Abutment — Cowellmedi Co., Ltd
- INNO Submerged Implant System-Absolute Abutment — Cowellmedi Co., Ltd
- INNO Submerged Implant System-Absolute Abutment — Cowellmedi Co., Ltd
- INNO Submerged Implant System-Angulated Abutment — Cowellmedi Co., Ltd
- INNO Submerged Implant System-Angulated Abutment — Cowellmedi Co., Ltd
- INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd
- INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd
- INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd
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
- Cowellmedi Co., Ltd
Sources (1)
- FDA UDI 10d23aeb-deed-4855-a4e4-d8e510faaa3c 33 fields · synced Jun 6, 2026