T.A.G. Dental Implant System
FDA 510(k) K143326 · T.A.G. Medical Products Corporation, Ltd.
510(k) numberK143326
Submission
- Device name
- T.A.G. Dental Implant System
- Applicant
- T.A.G. Medical Products Corporation, Ltd.
Kibbutz Gatton, IL - Received
- November 20, 2014
- Decision date
- May 14, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260463 | ZEROS Dental Implant SystemDZE · Special | Zeros Co., Ltd. | 08/19/2026SE |
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| K250806 | Dental Implant SystemDZE · Traditional | A.B. Dental Devices , Ltd. | 06/18/2026SE |
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| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantDZE · Traditional | Promimic AB | 05/12/2026SE |
| K252031 | Adin Long Dental Implant SystemDZE · Traditional | Adin Dental Implant Systems , Ltd. | 03/23/2026SE |
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| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | Institut Straumann AG | 03/10/2026SE |
| K253493 | Dentis SQ-SL AXEL FixtureDZE · Traditional | Dentis Co., Ltd. | 03/04/2026SE |
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| K210498 | Betta Link Knotless Implant SystemMBI · Special | 03/24/2021SE |
| K202178 | VersaLoop Anchor SystemMBI · Traditional | 11/13/2020SE |
| K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…MBI · Traditional | 05/19/2019SE |
| K142653 | G-Lok and G-Lok XL ExtenderMBI · Special | 10/16/2014SE |
| K113297 | Knotilus Anchor SystemMBI · Traditional | 03/02/2012SE |
| K112296 | Lateral ButtonMBI · Traditional | 12/01/2011SE |
Questions and answers
When was T.A.G. Dental Implant System cleared by the FDA?
T.A.G. Dental Implant System (K143326) received a 510(k) decision of Substantially Equivalent on May 14, 2015, 175 days after the submission was received.
What is the product code of K143326?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.