ELW · Class II · 21 CFR 872.3660

FDA Product Code ELW: Material, Impression

Leading manufacturers include Dentsply Intl., Heraeus Kulzer, Inc. and GC America, Inc..

402

Total

402

Cleared

95d

Avg days

1976

Since

402 devices

49–72 of 402

1 2 3 4 5 6

Cleared Oct 20, 2003

GC America, Inc.

Cleared Oct 02, 2003

ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)

Harry J. Bosworth Co.

Cleared Apr 03, 2003

Heraeus Kulzer, Inc.

Cleared Jan 22, 2003

GC America, Inc.

Cleared Oct 18, 2002

GC America, Inc.

Cleared Aug 14, 2002

REGISTRADO X-TRA

Cleared May 13, 2002

AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL

Cleared May 10, 2002

AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL

Cleared May 08, 2002

AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL

Cleared Nov 01, 2001

CEREC3 VITABLOCKS

Sirona Dental Systems GmbH

Cleared Sep 04, 2001

EXTRUDE MODIFIED

Sybron Dental Specialties, Inc.

Cleared Mar 01, 2001

Sybron Dental Specialties, Inc.

Cleared Feb 15, 2001

Sybron Dental Specialties, Inc.

Cleared Feb 01, 2001

FLEXTIME MAGNUM 360

Heraeus Kulzer, Inc.

Cleared Jul 21, 2000

Sybron Dental Specialties, Inc.

Cleared Jul 05, 2000

Jeneric/Pentron, Inc.

Cleared Apr 13, 2000

ACTIVATOR PASTE

Harry J. Bosworth Co.

Cleared Apr 05, 2000

Heraeus Kulzer, Inc.

Cleared Feb 08, 2000

Sirona Dental Systems GmbH

Cleared Jan 27, 2000

AROMA FINE (NORMAL AND FAST SET)

GC America, Inc.

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 15, 1999

XANTOPREN COMFORT

Heraeus Kulzer, Inc.

1 2 3 4 5 6