FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS

K Number: K061500 · Decision Aug 8, 2006
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
5
Review Days
69

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS
K Number
K061500
Device Class
FDA class 2
Clearance Type
Abbreviated
Regulation Number
872.3640
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Sic Invent AG
Date Received
May 31, 2006
Decision Date
August 8, 2006
Product Code
DZE
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
DZE Implant, Endosseous, Root-Form

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (DZE), ordered by most recent decision date.

View all

Other Clearances by Sic Invent AG

K Number Device Name
K252904 SIC Abutments including CAD/CAM Solutions
K210489 SICtapered & SICvantage tapered
K173207 SIC invent Dental Implant Systems
K040757 SIC PRO