510(k) K101545 ยท DZE Implant, Endosseous, Root-Form
GENESIS IMPLANT SYSTEM
| Applicant | Keystone Dental, Burlington MA, US |
| Decision | Substantially Equivalent, Oct 28, 2010 |
| Received | Jun 3, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K101545
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2018 | Keystone Dental Inc Genesis Surgical Cassette Tapered
Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket Terminated |
DZE | None listed |
| Mar 8, 2013 | Keystone Dental Inc Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment
Part Number: G71200
Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandible Terminated |
NHA | None listed |
| Mar 8, 2013 | Keystone Dental Inc Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment
Part Number: G71205
Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandib Terminated |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.