Class Class II
DenQ Sub SLA Implant System (K240977)
Description
DenQ Sub SLA Implant System by Denq, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240977
Clearance Date2024-09-13
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240977
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. DenQ Sub SLA Implant System (K240977) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230108 | Straumann® BLC and TLC Implants | Institut Straumann AG | 2023 |
| K222707 | IH Implant System | Sewonmedix, Inc. | 2023 |
| K213576 | Tatum Surgical Dental Implant System | Suncoast Dental, Inc. Dba Tatum Sur... | 2022 |
| K122995 | INTENSE PULSED LIGHT (IPL) SYSTEMS | Beijing Kes Biology Technology Co.,... | 2013 |
| K121995 | TS FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2012 |
Trace the full predicate network for K240977
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.