Product Code: EGD FDA class 1 21 CFR 872.6890

Wax, Dental, Intraoral

Dental

The Intraoral Dental Wax is a dental material used inside the mouth for a variety of purposes including bite registration, boxing impressions, constructing occlusal rims, and blocking undercuts during prosthetic fabrication, formulated to be safe for intraoral use. It is classified as FDA Class 1, the lowest risk category, and is GMP exempt, meaning it is also exempt from most good manufacturing practice requirements. The product code is EGD and the applicable regulation is 21 CFR 872.6890, under the Dental medical specialty.

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510(k)s

FEI Numbers

198

Registration Numbers

198

Unique Applicants

Years Active

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Basic Information

Product Code: EGD
Device Class: FDA class 1
Regulation Number: 872.6890
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 25 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K020009	BRACE EZE	Feb 11, 2002	Substantially Equivalent	Udent, Inc.
K945535	GLENROE ORTHO-SIL	Jan 27, 1995	Substantially Equivalent	Glenroe Technologies
K924024	ORTHO WAX	Nov 17, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K923586	BURNOUT MATERIAL	Sep 29, 1992	Substantially Equivalent	Dentsply Intl.
K914892	SALIVA-STIM	Sep 02, 1992	Substantially Equivalent	Orion Diagnostica, Inc.
K922380	BITE RIM WAX	Jun 16, 1992	Substantially Equivalent	Dentsply Intl.
K914513	PALAVIT G	Mar 19, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K910676	INTRAORAL DENTAL WAX	Aug 21, 1991	Substantially Equivalent	Pemaco, Inc.
K904928	PALAVIT GLC	Jun 06, 1991	Substantially Equivalent	Kulzer, Inc.
K895566	PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT	Nov 06, 1989	Substantially Equivalent	Pemaco, Inc.
K895564	PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD	Nov 06, 1989	Substantially Equivalent	Pemaco, Inc.
K895563	PEMACO BITE WAX SHEETS	Nov 06, 1989	Substantially Equivalent	Pemaco, Inc.
K895562	PEMACO 2000 INTRAORAL DENTAL WAX	Nov 06, 1989	Substantially Equivalent	Pemaco, Inc.
K895561	PEMACO 3000 INTRAORAL DENTAL WAX	Nov 06, 1989	Substantially Equivalent	Pemaco, Inc.
K895565	PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD	Oct 24, 1989	Substantially Equivalent	Pemaco, Inc.
K880607	UTILITY WAX STRIPS, SPEARMINT	Mar 31, 1988	Substantially Equivalent	Columbus Dental Mfg. Co.
K880606	UTILITY WAX STRIPS, CINNAMON	Mar 24, 1988	Substantially Equivalent	Columbus Dental Mfg. Co.
K863758	ORTHO-BITE WAX WAFER	Oct 07, 1986	Substantially Equivalent	Columbus Dental Mfg. Co.
K854529	INLAY WAX REGULAR	Mar 10, 1986	Substantially Equivalent	The Hygenic Corp.
K854530	PREMIUM FLEXI-TOUGH	Mar 04, 1986	Substantially Equivalent	The Hygenic Corp.
K854527	STICKY WAX	Mar 04, 1986	Substantially Equivalent	The Hygenic Corp.
K850915	WAX BITE IMPRESSION WAFER	Apr 16, 1985	Substantially Equivalent	Toothprints, Inc.
K812804	MODERN MATERIALS' INLAY CSTG. WAXES,A-C	Jan 26, 1982	Substantially Equivalent	Modern Materials
K812805	STEELE'S ECON. PINK BASEPL. WAXES, I-III	Jan 12, 1982	Substantially Equivalent	Modern Materials
K801911	HOWMEDICA BITE BLOCK	Aug 27, 1980	Substantially Equivalent	Howmedica Corp.