INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM— 510(k) K130572
Substantially EquivalentImplant Direct Sybron Manufacturing, LLC
FDA 510(k) clearance K130572 for INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM, Substantially Equivalent on 2013-12-24. Applicant: Implant Direct Sybron Manufacturing, LLC. Device class: 2.
Clearance details
- Applicant
- Implant Direct Sybron Manufacturing, LLC
- 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
- Calabasas, CA, US
Recent devices under product code DZE
view allMore clearances from Implant Direct Sybron Manufacturing, LLC
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 K130572
K-number listed on FDA's recall record- Z-0363-2020 — Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
- Z-1917-2018 — ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
- Z-0539-2018 — Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
- Z-2551-2018 — ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130572.
Data sourced from openFDA. This site is unofficial and independent of the FDA.