# K112795: Paltop Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Paltop Advanced Dental Solutions, Ltd.
- Decided: Apr 20, 2012 after 207 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K960026 (1996). 90 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063364: Alpha Bio Dental Implant System, Alpha-Bio Tec, Ltd. (2007) Summary page 1.
- K040807: Mis Dental Implant System, Mis - Implant Technologies, Ltd. (2004) Summary page 1.
- K080156: Osseospeed TM  Profile System, Astra Tech AB (2008) Summary page 2.
- K091239: Astra Tech Implant System, Astra Tech AB (2009) Summary page 2.
- K071803: Ards Dental Implants, Ards, Ltd. (2008) Summary page 3.
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 2.

## Most influential descendants
- K130462: Paltop Narrow Implant, Paltop Short Implant (2013), 8 descendants of its own
- K210117: Paltop Narrow Implant (2021), 5 descendants of its own
- K220200: Paltop Conical Implant System (2022), 2 descendants of its own
- K231395: INNO SLA Submerged Narrow Implant System (2023), 1 descendant of its own
- K190849: IS-III active System_S-narrow Type (2019), 1 descendant of its own

## Recalls of this device
- May 30, 2019 · Class II · Z-0019-2020: Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant.
- Feb 22, 2019 · Class II · Z-1064-2019: Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
- Feb 22, 2019 · Class II · Z-1061-2019: Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
- Feb 22, 2019 · Class II · Z-1062-2019: Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
- Feb 22, 2019 · Class II · Z-1063-2019: Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature

## Indications for use
The Paltop Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K112795
Methodology: https://510kreport.com/methodology