Class Class II
Mini Screws (K231502)
Description
Mini Screws by Proimtech Saglik Urunleri Anonim Sirketi, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK231502
Clearance Date2024-09-04
Clearance TypeTraditional
Product CodeOAT
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231502
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. Mini Screws (K231502) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191041 | Orthodontic Fixation Screw [Smart Anchor Miniscrew] | Gni Co., Ltd. | 2020 |
| K161197 | Orthodontic Screw | Osstem Implant Co., Ltd. | 2016 |
| K152297 | OBS Anchorage Screw | Bomei Co, Ltd. | 2016 |
Trace the full predicate network for K231502
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.