SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D,

Implant, Endosseous, Root-form

CORE-VENT CORP.

The following data is part of a premarket notification filed by Core-vent Corp. with the FDA for Swissplus Implant System, Model Spwb 8,10,12,14/oph20/smpr, Spb 8,10,12,14/op3.5d/opar,opb 8,10,12,14/op2.3d/op2.8d,.

Pre-market Notification Details

Device IDK002188
510k NumberK002188
Device Name:SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D,
ClassificationImplant, Endosseous, Root-form
Applicant CORE-VENT CORP. 4630 SOUTH ARVILLE STE D Las Vegas,  NV  89103
ContactWill Fisher
CorrespondentWill Fisher
CORE-VENT CORP. 4630 SOUTH ARVILLE STE D Las Vegas,  NV  89103
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-20
Decision Date2000-10-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024014923 K002188 000
00889024016057 K002188 000
00889024017177 K002188 000
00889024017184 K002188 000
00889024017191 K002188 000
00889024017207 K002188 000
00889024017467 K002188 000
00889024017474 K002188 000
00889024017481 K002188 000
00889024017498 K002188 000
00889024017528 K002188 000
00889024016040 K002188 000
00889024016033 K002188 000
00889024016026 K002188 000
00889024015739 K002188 000
00889024015746 K002188 000
00889024015791 K002188 000
00889024015807 K002188 000
00889024015814 K002188 000
00889024015821 K002188 000
00889024015869 K002188 000
00889024015876 K002188 000
00889024015883 K002188 000
00889024015968 K002188 000
00889024017566 K002188 000
00889024017573 K002188 000
00889024017580 K002188 000
00889024015982 K002188 000
00889024015999 K002188 000
00889024016064 K002188 000
00889024016071 K002188 000
00889024017412 K002188 000
00889024017436 K002188 000
00889024017443 K002188 000
00889024017535 K002188 000
00889024017542 K002188 000
00889024017559 K002188 000
00889024015975 K002188 000
00889024015944 K002188 000
00889024015937 K002188 000
00889024017597 K002188 000
00889024015715 K002188 000
00889024015722 K002188 000
00889024015753 K002188 000
00889024015760 K002188 000
00889024015784 K002188 000
00889024015838 K002188 000
00889024015845 K002188 000
00889024015913 K002188 000
00889024015920 K002188 000
00889024020238 K002188 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.