EGD · Class I · 21 CFR 872.6890

FDA Product Code EGD: Wax, Dental, Intraoral

Leading manufacturers include Pemaco, Inc., The Hygenic Corp. and Columbus Dental Mfg. Co..

25

Total

25

Cleared

90d

Avg days

1980

Since

FDA 510(k) Cleared Wax, Dental, Intraoral Devices (Product Code EGD)

25 devices

1–24 of 25

Cleared Feb 11, 2002

Cleared Jan 27, 1995

GLENROE ORTHO-SIL

Glenroe Technologies

Cleared Nov 17, 1992

Heraeus Kulzer, Inc.

Cleared Sep 29, 1992

BURNOUT MATERIAL

Cleared Sep 02, 1992

Orion Diagnostica, Inc.

Cleared Jun 16, 1992

Cleared Mar 19, 1992

Heraeus Kulzer, Inc.

Cleared Aug 21, 1991

INTRAORAL DENTAL WAX

Cleared Jun 06, 1991

Cleared Nov 06, 1989

PEMACO 3000 INTRAORAL DENTAL WAX

Cleared Nov 06, 1989

PEMACO 2000 INTRAORAL DENTAL WAX

Cleared Nov 06, 1989

PEMACO BITE WAX SHEETS

Cleared Nov 06, 1989

PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD

Cleared Nov 06, 1989

PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT

Cleared Oct 24, 1989

PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD

Cleared Mar 31, 1988

UTILITY WAX STRIPS, SPEARMINT

Columbus Dental Mfg. Co.

Cleared Mar 24, 1988

UTILITY WAX STRIPS, CINNAMON

Columbus Dental Mfg. Co.

Cleared Oct 07, 1986

ORTHO-BITE WAX WAFER

Columbus Dental Mfg. Co.

Cleared Mar 10, 1986

INLAY WAX REGULAR

The Hygenic Corp.

Cleared Mar 04, 1986

The Hygenic Corp.

Cleared Mar 04, 1986

PREMIUM FLEXI-TOUGH

The Hygenic Corp.

Cleared Apr 16, 1985

WAX BITE IMPRESSION WAFER

Toothprints, Inc.

Cleared Jan 26, 1982

MODERN MATERIALS' INLAY CSTG. WAXES,A-C

Modern Materials

Cleared Jan 12, 1982

STEELE'S ECON. PINK BASEPL. WAXES, I-III

Modern Materials

About Product Code EGD - Regulatory Context

Related FDA 510(k) Regulatory Insights