SPECTRA SYSTEM— 510(k) K061319
Substantially EquivalentImplant Direct, LLC
FDA 510(k) clearance K061319 for SPECTRA SYSTEM, Substantially Equivalent on 2006-09-29. Applicant: Implant Direct, LLC. Device class: 2.
Clearance details
- Applicant
- Implant Direct, 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, 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 K061319
K-number listed on FDA's recall record- Z-0010-2020 — ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
- Z-2376-2018 — REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
- Z-2125-2017 — Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
- Z-2320-2016 — RePlant¿ Angled Abutment Part Number 6050-52-60
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061319.
Data sourced from openFDA. This site is unofficial and independent of the FDA.