PALTOP DENTAL IMPLANT SYSTEM— 510(k) K112795
Substantially EquivalentPaltop Advanced Dental Solutions, Ltd.
FDA 510(k) clearance K112795 for PALTOP DENTAL IMPLANT SYSTEM, Substantially Equivalent on 2012-04-20. Applicant: Paltop Advanced Dental Solutions, Ltd.. Device class: 2.
Clearance details
- Applicant
- Paltop Advanced Dental Solutions, Ltd.
- Product code
- Code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Caesarea, IL
Recent devices under product code DZE
view allMore clearances from Paltop Advanced Dental Solutions, Ltd.
view allAdverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K112795
K-number listed on FDA's recall record- Z-0019-2020 — Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
- Z-1061-2019 — Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112
- Z-1062-2019 — Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021
- Z-1063-2019 — Paltop 1.25 Hex Drivers, Long Part Number: 60-70101
- Z-1064-2019 — Paltop 1.25 Hex Drivers, Short Part Number: 60-70102
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112795.
Data sourced from openFDA. This site is unofficial and independent of the FDA.