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Sign in to claim this brandDENTIS CO. , LTD
US
Last updated May 23, 2026
What DENTIS CO. , LTD makes
DENTIS Co., Ltd manufactures dental implant components, including permanent and temporary preformed suprastructures, two-piece screw endosteal implants, and reusable surgical tools such as fluted drill bits, fixture drill bits, and screwdrivers. Their portfolio also includes dental/maxillofacial surgical procedure kits, operating room lighting systems, and specialized abutments like the s-Clean and i-Clean series, along with fixtures and spacers for implant procedures.
The company’s devices are regulated under FDA’s Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 694721181
Catalogue (5993)
Page 120 of 120| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HAPTITE s-Clean tapered Fixture | DSFW4814H | FDA UDI | Class II | Active |
| s-Clean TiN Half Coating Couple Abutment | DSCA5515H4HCT | FDA UDI | Class II | Active |
| i-Clean ScanBody | DISBS | EUDAMEDFDA UDI | Class I | Active |
| s-Clean Pick-Up Impression Coping Guide Pin | DSGPS10 | EUDAMEDFDA UDI | Class I | Active |
| s-Clean SQ-SL Fixture Mini | DSSFM8008S | FDA UDI | Class II | Active |
| s-Clean TiN Half Coating Couple Abutment s-Line Mini | DSCAMZ4520HTS | FDA UDI | Class II | Active |
| s-Clean Sole Abutment | DSSAS40105 | FDA UDI | Class II | Active |
| s-Clean Free-Healing Abutment | DSFH5545 | FDA UDI | Class II | Active |
| s-Clean FreeMill Abutment | DSFMA7540N | FDA UDI | Class II | Active |
| s-Clean Pre-Milled Abutment | K210362 | FDA 510(k) | Class II | Active |
| Save Gbr | K222367 | FDA 510(k) | Class II | Active |
| Dentis s-Clean SQ-SL Fixture | K240511 | FDA 510(k) | Class II | Active |
| s-Clean TiN Coating Abutments | K171694 | FDA 510(k) | Class II | Active |
| s-Clean ScanHealing Abutment | K241063 | FDA 510(k) | Class II | Active |
| OneQ-SL s-Clean Implant System | K170220 | FDA 510(k) | Class II | Active |
| OneQ-SL Implant System | K142313 | FDA 510(k) | Class II | Active |
| Dentis s-Clean Abutment Mini | K220440 | FDA 510(k) | Class II | Active |
| s-Clean SQ-SL Implant System Mini | K202773 | FDA 510(k) | Class II | Active |
| Mesheet | K233544 | FDA 510(k) | Class II | Active |
| s-Clean Link Abutment Narrow | K230523 | FDA 510(k) | Class II | Active |
| Dentis s-Clean s-Line | K210134 | FDA 510(k) | Class II | Active |
| Dentis s-Clean SQ-SL Narrow Implant System | K230246 | FDA 510(k) | Class II | Active |
| s-Clean SQ-SL Implant System Regular | K210132 | FDA 510(k) | Class II | Active |
| Dentis SQ-SL AXEL Fixture | K253493 | FDA 510(k) | Class II | Active |
| s-Clean SQ-SL Implant System Mini | K200099 | FDA 510(k) | Class II | Active |
| Dentis I-FIX Abutment | K230203 | FDA 510(k) | Class II | Active |
| s-Clean Link Abutment | K222913 | FDA 510(k) | Class II | Active |
| Dentis s-Clean Regular Abutment | K230126 | FDA 510(k) | Class II | Active |
| I-Fix System | K083586 | FDA 510(k) | Class II | Active |
| Save Gbr | K222451 | FDA 510(k) | Class II | Active |
| s-Clean SQ-SL Implant System Regular | K192688 | FDA 510(k) | Class II | Active |
| Luvis Chair (LC700C) | K233921 | EUDAMEDFDA 510(k) | Class I | Active |
| Resin for Temporary Crown & Bridge | K180657 | FDA 510(k) | Class II | Active |
| s-Clean Tapered II RBM Implant System | K160213 | FDA 510(k) | Class II | Active |
| OneQ-SL s-Clean Implant System | K153639 | FDA 510(k) | Class II | Active |
| Dentis i-Clean System | K230307 | FDA 510(k) | Class II | Active |
| s-Clean Pre-Milled Abutment Mini | K210410 | FDA 510(k) | Class II | Active |
| Modificaton To: Dentis Dental Implant System | K082843 | FDA 510(k) | Class II | Active |
| Dentis s-Clean s-Line Mini | K210080 | FDA 510(k) | Class II | Active |
| s-Clean OneQ-SL Narrow Implant System | K161244 | FDA 510(k) | Class II | Active |
| Haptite Coating Implant System | K111364 | FDA 510(k) | Class II | Active |
| ChecQ (AC100) | K241065 | FDA 510(k) | Class I | Active |
| MU System | K222976 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Dentis Co., Ltd. Daegu · KR FEI 3007031098