GENESIS IMPLANT SYSTEM— 510(k) K101545
Substantially EquivalentKeystone Dental
FDA 510(k) clearance K101545 for GENESIS IMPLANT SYSTEM, Substantially Equivalent on 2010-10-28. Applicant: Keystone Dental. Device class: 2.
Clearance details
- Applicant
- Keystone Dental
- 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
- Abbreviated
- Location
- Burlington, MA, US
Recent devices under product code DZE
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 K101545
K-number listed on FDA's recall record- Z-1485-2018 — Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
- Z-0923-2013 — 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 mandibles and maxillae.
- Z-0924-2013 — 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 mandibles and maxillae.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101545.
Data sourced from openFDA. This site is unofficial and independent of the FDA.