ELM · Class II · 21 CFR 872.3590

FDA Product Code ELM: Denture, Plastic, Teeth

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

55
Total
55
Cleared
106d
Avg days
1977
Since
55 devices
49–55 of 55
Cleared May 09, 1983
DELTA TEETH
K831214
Dentsply Intl.
Dental · 25d
Cleared May 05, 1981
ISOSIT TEETH
K810970
Bauer, Cheng & Associates, Inc.
Dental · 26d
Cleared Jun 20, 1980
REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN
K801235
Oki Shiks USA , Ltd.
Dental · 24d
Cleared Jan 04, 1980
TEETH, DENTURE, PLASTIC
K792245
Dentsply Intl.
Dental · 58d
Cleared Mar 15, 1978
ANTERIORS AND POSTERIORS, PLASTIC
K780217
Dentsply Intl.
Dental · 33d
Cleared Aug 26, 1977
SHELL VENEER
K771398
L.D. Caulk Co.
Dental · 28d