Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
- 510(k)K100887Substantially equivalent (SESE) · 2010-08-09clearance family
Manufacturer compliance record
None in the loaded window.
Similar devices
- DS Implants Dentsply Implants Manufacturing GmbH
- DS Implants Dentsply Implants Manufacturing GmbH
- DS OmniTaper Dentsply Implants Manufacturing GmbH
- DS Prime Taper Dentsply Implants Manufacturing GmbH
- InterActive® Surgical Kit IMPLANT DIRECT SYBRON MANUFACTURING LLC
- InterActive®Surgical Kit Mini IMPLANT DIRECT SYBRON MANUFACTURING LLC
- """SURGICAL KIT """"ONEBOX""""""" SWEDEN & MARTINA SPA
- """SURGICAL KIT """"ONEBOX2""""""" SWEDEN & MARTINA SPA
- "Burkhart Sterile Pouches 2-1/4""X4"" 200/pkg" BURKHART DENTAL SUPPLY CO., THE
- "Burkhart Sterile Pouches 2-3/4""X10"" 200/pkg" BURKHART DENTAL SUPPLY CO., THE
- "Burkhart Sterile Pouches 3-1/2""/x10"" 200/pkg" BURKHART DENTAL SUPPLY CO., THE
- "Burkhart Sterile Pouches 3-1/2""X5-1/4"" 200/pkg" BURKHART DENTAL SUPPLY CO., THE
Select up to two to place side-by-side with this device.