IU Implant System
510(k) K172345
IU Implant System is a Class II device made by WARANTEC.Co., Ltd, cleared under FDA 510(k) K172345 on 18 Jun 2018, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172345 | Date18 Jun 2018 | StatusActive |
Official records
- FDA 510(k) database K172345
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DZE
- FDA applicant
- Warantec Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K172345
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| IU Abutment Screw ISUASL | ISUASL | 08800026104872 | On the market | |
| IU Attachment Retained Abutment IULA4360A | IULA4360A | 08800026104476 | On the market | |
| IU Ball Attachment Abutment IUBA4020A | IUBA4020A | 08800026104315 | On the market | |
| IU Ball Attachment Abutment IUBA4060A | IUBA4060A | 08800026104353 | On the market | |
| IU Ball Attachment Abutment IUBA5020 | IUBA5020 | 08800026104377 | On the market | |
| IU Ball Attachment Abutment IUBA5040 | IUBA5040 | 08800026104391 | On the market | |
| IU Cover Screw IUCSA | IUCSA | 08800026106500 | On the market | |
| IU Fixture FIU45070 | FIU45070 | 08800026100911 | On the market | |
| IU Fixture FIU45100 | FIU45100 | 08800026100935 | On the market | |
| IU Fixture FIU50085 | FIU50085 | 08800026100973 | On the market | |
| IU Fixture FIU55085 | FIU55085 | 08800026101024 | On the market | |
| IU Fixture FIU55100 | FIU55100 | 08800026101031 | On the market | |
| IU Healing Abutment IUHA4030A | IUHA4030A | 08800026102274 | On the market | |
| IU Healing Abutment IUHA5050 | IUHA5050 | 08800026102472 | On the market | |
| IU Healing Abutment IUHA6020 | IUHA6020 | 08800026102502 | On the market | |
| IU Healing Abutment IUHA6030 | IUHA6030 | 08800026102519 | On the market | |
| IU SB Abutment Φ4.0 IUSB4017A | IUSB4017A | 08800026103714 | On the market | |
| IU SB Abutment Φ4.0 IUSB4034A | IUSB4034A | 08800026108771 | On the market | |
| IU SB Abutment Φ4.0 IUSB4055 | IUSB4055 | 08800026103424 | On the market | |
| IU SB Abutment Φ5.0 IUSB5024 | IUSB5024 | 08800026108856 | On the market | |
| IU SB Abutment Φ5.0 IUSB5047 | IUSB5047 | 08800026103530 | On the market | |
| IU SB Abutment Φ6.0 IUSB6015 | IUSB6015 | 08800026103585 | On the market | |
| IU SB Abutment Φ6.0 IUSB6037 | IUSB6037 | 08800026103639 | On the market | |
| IU SB Abutment_hex Φ4.0 IUSB4024H | IUSB4024H | 08800026109136 | On the market | |
| IU SB Abutment_hex Φ4.0 IUSB4024HA | IUSB4024HA | 08800026109143 | On the market | |
| IU SB Abutment_hex Φ4.0 IUSB4035HA | IUSB4035HA | 08800026103264 | On the market | |
| IU SB Abutment_hex Φ4.0 IUSB4044H | IUSB4044H | 08800026109174 | On the market | |
| IU SB Abutment_hex Φ4.0 IUSB4044HA | IUSB4044HA | 08800026109181 | On the market | |
| IU SB Abutment_hex Φ4.0 IUSB4065HA | IUSB4065HA | 08800026103325 | On the market | |
| IU SB Abutment_hex Φ5.0 IUSB5015H | IUSB5015H | 08800026102984 | On the market | |
| IU SB Abutment_hex Φ5.0 IUSB5045H | IUSB5045H | 08800026103042 | On the market | |
| IU SB Abutment_hex Φ5.0 IUSB5054H | IUSB5054H | 08800026109273 | On the market | |
| IU SB Abutment_hex Φ5.0 IUSB5065H | IUSB5065H | 08800026103080 | On the market | |
| IU SB Abutment_hex Φ6.0 IUSB6015H | IUSB6015H | 08800026103103 | On the market | |
| IU SB Abutment_Non hex Φ4.0 IUSB4017NA | IUSB4017NA | 08800026104193 | On the market | |
| IU SB Abutment_Non hex Φ4.0 IUSB4025NA | IUSB4025NA | 08800026104209 | On the market | |
| IU SB Abutment_Non hex Φ4.0 IUSB4035N | IUSB4035N | 08800026103868 | On the market | |
| IU SB Abutment_Non hex Φ4.0 IUSB4035NA | IUSB4035NA | 08800026104223 | On the market | |
| IU SB Abutment_Non hex Φ4.0 IUSB4047N | IUSB4047N | 08800026103899 | On the market | |
| IU SB Abutment_Non hex Φ4.0 IUSB4055NA | IUSB4055NA | 08800026104261 | On the market | |
| IU SB Abutment_Non hex Φ5.0 IUSB5014N | IUSB5014N | 08800026109419 | On the market | |
| IU SB Abutment_Non hex Φ5.0 IUSB5024N | IUSB5024N | 08800026109426 | On the market | |
| IU SB Abutment_Non hex Φ5.0 IUSB5054N | IUSB5054N | 08800026109457 | On the market | |
| IU SB Abutment_Non hex Φ5.0 IUSB5057N | IUSB5057N | 08800026104032 | On the market | |
| IU SB Abutment_Non hex Φ5.0 IUSB5065N | IUSB5065N | 08800026104049 | On the market | |
| IU SB Abutment_Non hex Φ6.0 IUSB6027N | IUSB6027N | 08800026104094 | On the market | |
| IU Temporary cylinder_hex IUTCHA | IUTCHA | 08800026104889 | On the market | |
| IU Top Abutment_hex Φ3.8 I0UTA3824HA | I0UTA3824HA | 08800026123347 | On the market | |
| IU Top Abutment_hex Φ3.8 I0UTA3854HA | I0UTA3854HA | 08800026123361 | On the market | |
| UT Fixture FUT48100 | FUT48100 | 08800026101161 | On the market |
Similar devices
Other devices filed under FDA product code DZE (Implant, Endosseous, Root-Form).
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- TREFOIL System by Nobel Biocare AB
- NSI HEXED AND NON-HEXED IMPLANT SYSTEM by Nsi