510(k) K090234 ยท DZE Implant, Endosseous, Root-Form
SPECTRA SYSTEM DENTAL IMPLANTS 2008
| Applicant | Implant Direct, LLC, Calabasas CA, US |
| Decision | Substantially Equivalent, May 15, 2009 |
| Received | Jan 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090234
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2020 | Implant Direct Sybron Manufacturing LLC Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R, Terminated |
DZE | None listed |
| Feb 4, 2020 | Implant Direct Sybron Manufacturing LLC Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213 Terminated |
DZE | None listed |
| Nov 12, 2019 | Implant Direct Sybron Manufacturing, LLC Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA
Dental Implants Terminated |
DZE | None listed |
| Aug 8, 2018 | Implant Direct Sybron Manufacturing, LLC ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216.
The responsible firm on the Terminated |
DZE | None listed |
| Jan 19, 2018 | Implant Direct Sybron Manufacturing, LLC SwishTapered Implant
Intended for use in support for fixed bridgework. Terminated |
DZE | None listed |
| Oct 10, 2017 | Implant Direct Sybron Manufacturing, LLC ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713
This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and Terminated |
DZE | None listed |
| Jul 21, 2017 | Implant Direct Sybron Manufacturing, LLC Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component. Terminated |
NHA | None listed |
| Jan 28, 2017 | Implant Direct Sybron Manufacturing, LLC SwishTapered Implant Terminated |
DZE | None listed |
| Jan 9, 2017 | Implant Direct Sybron Manufacturing, LLC GoDirect Screw-Retaining Top
Part Numbers: 4500-61 Terminated |
DZE | None listed |
| Nov 15, 2016 | Implant Direct Sybron Manufacturing, LLC ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL. Terminated |
DZE | None listed |
| Mar 4, 2016 | Implant Direct Sybron Manufacturing, LLC The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system.
GoDirect Implants
Part Number: 423011, 423013, 4 Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.