SWISSPLANT DENTAL IMPLANT SYSTEM— 510(k) K081396
Substantially EquivalentImplant Direct, LLC
FDA 510(k) clearance K081396 for SWISSPLANT DENTAL IMPLANT SYSTEM, Substantially Equivalent on 2009-01-14. Applicant: Implant Direct, LLC. Device class: 2.
Clearance details
- Applicant
- Implant Direct, LLC
- Product code
- Code NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Calabasas, CA, US
Recent devices under product code NHA
view allMore clearances from Implant Direct, LLC
view allAdverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
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 K081396
K-number listed on FDA's recall record- Z-1126-2020 — SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
- Z-1168-2018 — SwishPlus Implant Intended for use in support for fixed bridgework.
- Z-0396-2016 — DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081396.
Data sourced from openFDA. This site is unofficial and independent of the FDA.