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INNO Submerged Implant System-Cemented Abutment
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 2SCH4545Ref IT5008SM
Identity
- Trade Name
- INNO Implant System EUDAMEDINNO Submerged Implant System-Cemented Abutment FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- INNO Sub. Abutment EUDAMEDINNO Int. Fixture EUDAMED
- Model / Reference
- 2SCH4545 EUDAMEDFDA UDIIT5008SM EUDAMED2SCHW554 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809471721160 EUDAMEDFDA UDI08809471726943 EUDAMED08809471720675 FDA UDI
- Basic UDI-DI
- B-08809471721160 EUDAMEDB-08809471726943 EUDAMED
- 510(k) Number
- K132242 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental prosthesis/implant abutment screw FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMED
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental prosthesis/implant abutment screw
INNO Submerged Implant System-Cemented Abutment by Cowellmedi Co., Ltd — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis/implant abutment screw.
- Azure — TERRATS MEDICAL SL. · Class II
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class II
- Implant Prosthetics — PREAT Corporation · Class II
- MEDENTiKA — Medentika GmbH · Class II
- Azure — TERRATS MEDICAL SL. · Class II
- Recharge Kit w/ POC, TiLobe — SMART DENTURE CONVERSIONS, LLC · Class I
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 (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
- Cowellmedi Co., Ltd
Sources (4)
- FDA UDI e88df9dd-8ab7-4a4c-9cec-3ba10a5b0c99 33 fields · synced Jul 24, 2026
- FDA UDI e04455df-637e-4362-9c00-f3aac04cce0b 33 fields · synced May 30, 2026
- EUDAMED edae0b65-e065-44c2-b57a-f1304a6d4c13 61 fields · synced Jul 12, 2026
- EUDAMED 440b4159-71a4-4e03-ba61-fb6bd2863df8 61 fields · synced Jul 24, 2026