ELM · Class II · 21 CFR 872.3590

FDA Product Code ELM: Denture, Plastic, Teeth

Leading manufacturers include Ivoclar Vivadent, Inc., Dentsply Intl. and Heraeus Kulzer, Inc..

Total

Cleared

106d

Avg days

1977

Since

FDA 510(k) Cleared Denture, Plastic, Teeth Devices (Product Code ELM)

55 devices

1–24 of 55

Cleared Jan 14, 2014

SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S

K132984

Ivoclar Vivadent, Inc.

Shofu Dental Corporation

Shofu Dental Corporation

Ivoclar Vivadent, Inc.

Ivoclar Vivadent, Inc.

SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER

K023035

Ivoclar Vivadent, Inc.

SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH

K962456

Ivoclar North America, Inc.

VITAPAN ACRYLIC DENTURE TEETH

DENTURE PLASTIC TEETH,76 ELM

K915276

Nobelpharma USA, Inc.

TEETH, DENTURE, PLASTIC

ANTERIORS AND POSTERIORS, PLASTIC

K780217

Dentsply Intl.

Dental · 33d

FDA Product Code ELM: Denture, Plastic, Teeth

FDA 510(k) Cleared Denture, Plastic, Teeth Devices (Product Code ELM)

About Product Code ELM - Regulatory Context

Related FDA 510(k) Regulatory Insights