STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB— 510(k) K981516
Substantially EquivalentSterngold/Implamed
FDA 510(k) clearance K981516 for STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB, Substantially Equivalent on 1998-05-11. Applicant: Sterngold/Implamed. Device class: 2.
Clearance details
- Applicant
- Sterngold/Implamed
- 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
- Special
- Location
- Attleboro, MA, US
Recent devices under product code DZE
view allMore clearances from Sterngold/Implamed
view all- K984340 — STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281
- K984341 — STERNVANTAGE VARNISH LC, MODEL 221001
- K983786 — STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION
- K982692 — STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC
- K982895 — STERNOMEGA COMPOMER CEMENT
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.