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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K240232

EK D3.3 and Ultra Wide Implants · Hiossen, Inc. · decided 2024-09-13 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
EK III SA Fixture No MountCEK3S6010SHIOSSEN, INC.DZE00810126040596
EK III NH Fixture No MountCEK3S7013BHIOSSEN, INC.DZE00810126040336
EK III SA Fixture Pre-MountedAEK3S3010SHIOSSEN, INC.DZE00810126040367
EK III NH Fixture No MountCEK3S6008BHIOSSEN, INC.DZE00810126040244
EK III NH Fixture Pre-MountedAEK3S3008BHIOSSEN, INC.DZE00810126040015
EK III SA Fixture Pre-MountedAEK3S6007SHIOSSEN, INC.DZE00810126040404
EK III SA Fixture No MountCEK3S6007SHIOSSEN, INC.DZE00810126040572
EK III NH Fixture Pre-MountedAEK3S7008BHIOSSEN, INC.DZE00810126040138
EK III NH Fixture No MountCEK3S6011BHIOSSEN, INC.DZE00810126040268
EK III NH Fixture No MountCEK3S3010BHIOSSEN, INC.DZE00810126040190
EK III SA Fixture Pre-MountedAEK3S3008SHIOSSEN, INC.DZE00810126040350
EK III NH Fixture No MountCEK3S7011BHIOSSEN, INC.DZE00810126040329
EK III SA Fixture No MountCEK3S7013SHIOSSEN, INC.DZE00810126040671
EK III NH Fixture Pre-MountedAEK3S6006BHIOSSEN, INC.DZE00810126040053
EK III NH Fixture Pre-MountedAEK3S3007BHIOSSEN, INC.DZE00810126040008
EK III NH Fixture Pre-MountedAEK3S6010BHIOSSEN, INC.DZE00810126040084
EK III SA Fixture No MountCEK3S3011SHIOSSEN, INC.DZE00810126040541
EK III NH Fixture No MountCEK3S3008BHIOSSEN, INC.DZE00810126040183
EK III NH Fixture Pre-MountedAEK3S6008BHIOSSEN, INC.DZE00810126040077
EK III SA Fixture Pre-MountedAEK3S7010SHIOSSEN, INC.DZE00810126040480
EK III NH Fixture No MountCEK3S7007BHIOSSEN, INC.DZE00810126040299
EK III NH Fixture No MountCEK3S6013BHIOSSEN, INC.DZE00810126040275
EK III NH Fixture Pre-MountedAEK3S3011BHIOSSEN, INC.DZE00810126040039
EK III SA Fixture No MountCEK3S7011SHIOSSEN, INC.DZE00810126040664
EK III SA Fixture Pre-MountedAEK3S6006SHIOSSEN, INC.DZE00810126040398