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

25–48 of 55

Cleared Jul 05, 2001

Heraeus Kulzer, Inc.

Cleared Mar 27, 2001

WILLI GELLER CREAPEARL

Jensen Industries, Inc.

Cleared Apr 06, 2000

JELDENT BASIC LINE

J.F. Jelenko & Co.

Cleared Feb 07, 2000

ARTIFICIAL TEETH (ACRYLIC TEETH)

Masterdent Ltda.

Cleared Feb 12, 1999

NATURA DENTURE TEETH

Davis Schottlander & Davis, Ltd.

Cleared Feb 09, 1999

ENIGMA DENTURE TEETH

Davis Schottlander & Davis, Ltd.

Cleared Aug 06, 1996

SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH

Ivoclar North America, Inc.

Cleared Jun 13, 1994

DURODENT CORPORATION ARTIFICIAL PLASTIC TEETH

Cleared May 16, 1994

OPTODENT/OPTOGNATH

Spectrum Healthcare Group

Cleared May 02, 1994

VERIDENT PLUS, OPTIFORM

Cleared Feb 17, 1994

PRIMODENT ACRYLIC TEETH

Cleared Jun 24, 1993

Wilde-USA, Inc.

Cleared May 27, 1993

KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH

King Dental Corp.

Cleared Dec 23, 1992

NEW TOOTH MATERIAL

Cleared Nov 04, 1992

DENTURE PLASTIC TEETH

Cleared Mar 02, 1992

VITAPAN ACRYLIC DENTURE TEETH

Cleared Feb 03, 1992

DENTURE PLASTIC TEETH,76 ELM

Nobelpharma USA, Inc.

Cleared Jun 23, 1987

TRUETECH MEDICAL, INC. DENTURE CUPS

Zenex Medical, Inc.

Cleared Feb 10, 1987

SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH

Ivoclar USA, Inc.

Cleared Oct 31, 1985

AUSTENAL MODIFIED ACRYLIC DENTURE RESIN

Austenal Dental, Inc.

Cleared Aug 16, 1985

PREFORMED TOOTH ARCH

Swipes Dental Laboratory

Cleared Apr 08, 1985

KORVIN VITA RADIOPAQUE PLASTIC TEETH

Cleared Dec 03, 1984

SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS

Ivoclar USA, Inc.

Cleared Jul 31, 1984

NATURA-TONE OR LUXOPAL CL ACRYLIC

Parexel Intl. Corp.