ELW · Class II · 21 CFR 872.3660

FDA Product Code ELW: Material, Impression

Leading manufacturers include Zhermack S.P.A., Dentsply Intl. and Cavex Holland BV.

402

Total

402

Cleared

95d

Avg days

1976

Since

402 devices

145–168 of 402

4 5 6 7 8 9 10

Cleared Jul 05, 2000

Jeneric/Pentron, Inc.

Cleared May 25, 2000

KROM-ALGINATE AND ALGINATE PLUS

Cavex Holland BV

Cleared Apr 13, 2000

ACTIVATOR PASTE

Harry J. Bosworth Co.

Cleared Apr 11, 2000

Cleared Apr 05, 2000

DIMENSION PENTA L

Cleared Apr 05, 2000

Heraeus Kulzer, Inc.

Cleared Mar 30, 2000

DIMENSION GARANT L, DIMENSION GARANT L QUICK

Cleared Mar 30, 2000

DIMENSION PENTA H, DIMENSION PENTA H QUICK

Cleared Feb 08, 2000

Sirona Dental Systems GmbH

Cleared Jan 28, 2000

IMPREGUM PENTA M MONOSOFT

Cleared Jan 28, 2000

IMPREGUM PENTA DUOSOFT

Cleared Jan 27, 2000

AROMA FINE (NORMAL AND FAST SET)

GC America, Inc.

Cleared Jan 27, 2000

IMPREGUM GARANT L DUOSOFT

Cleared Nov 02, 1999

Silicon-Und Composite Spezialitaten GmbH

Cleared Sep 08, 1999

Cleared Sep 08, 1999

Cleared Jul 26, 1999

Harry J. Bosworth Co.

Cleared Jul 15, 1999

ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET)

Harry J. Bosworth Co.

Cleared Jul 15, 1999

ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)

Harry J. Bosworth Co.

Cleared Jun 18, 1999

Cleared Jun 15, 1999

XANTOPREN COMFORT

Heraeus Kulzer, Inc.

Cleared May 20, 1999

Cleared Feb 09, 1999

Cleared Oct 16, 1998

B-SYSTEM SILICONE

Sybron Dental Specialties, Inc.

4 5 6 7 8 9 10