STERNVANTAGE VARNISH LC, MODEL 221001— 510(k) K984341
Substantially EquivalentSterngold/Implamed
FDA 510(k) clearance K984341 for STERNVANTAGE VARNISH LC, MODEL 221001, Substantially Equivalent on 1999-01-08. Applicant: Sterngold/Implamed. Device class: 2.
Clearance details
- Applicant
- Sterngold/Implamed
- Product code
- Code EBI
- Device class
- Class 2
- Regulation
- 21 CFR 872.3760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Attleboro, MA, US
Recent devices under product code EBI
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view all- K984340 — STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281
- 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
- K981516 — STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB
Adverse events under product code EBI
product code EBI- Other
- 1
- Total
- 1
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.