Identity
- Trade Name
- IU SB Abutment Φ4.0 FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Model / Reference
- IUSB4037 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800026103394 FDA UDI
- 510(k) Number
- K172345 FDA UDI
- FDA Product Code
- NHA FDA UDIDZE FDA UDI
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant system
IU SB Abutment Φ4.0 by WARANTEC.Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant system.
- Healing abutment Regular — BIO CONCEPT Co., Ltd. · Class II
- Ball Attachment 5 mm — NOGA MEDICAL PRODUCTS LTD · Class II
- Equator Abutment, Φ 6.5mm, GH 2mm — BIO CONCEPT Co., Ltd. · Class II
- Short Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Implant Regular — BIO CONCEPT Co., Ltd. · Class II
- TRI — Tri Dental Implants Int. AG · Class II
Cleared under the same submission
K172345 also covers:
- IU Abutment Screw — WARANTEC.Co., Ltd
- IU Attachment Retained Abutment — WARANTEC.Co., Ltd
- IU Ball Attachment Abutment — WARANTEC.Co., Ltd
- IU Ball Attachment Abutment — WARANTEC.Co., Ltd
- IU Ball Attachment Abutment — WARANTEC.Co., Ltd
- IU Ball Attachment Abutment — WARANTEC.Co., Ltd
- IU Cover Screw — WARANTEC.Co., Ltd
- IU Fixture — WARANTEC.Co., Ltd
- IU Fixture — WARANTEC.Co., Ltd
- IU Fixture — WARANTEC.Co., Ltd
- IU Fixture — WARANTEC.Co., Ltd
- IU Fixture — WARANTEC.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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- WARANTEC.Co., Ltd
Sources (1)
- FDA UDI 1fd9e324-9c91-4fa3-ba05-4723289d7a97 33 fields · synced Jun 1, 2026