Product Code: EBH FDA class 1 21 CFR 872.3670

Material, Impression Tray, Resin

Dental

The Resin Impression Tray Material is a dental material used to fabricate custom impression trays that conform closely to a patient's dental arch, improving the accuracy and fit of the resulting impression compared to stock trays. 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 EBH and the applicable regulation is 21 CFR 872.3670, under the Dental medical specialty.

View on FDA

510(k)s

FEI Numbers

187

Registration Numbers

187

Unique Applicants

Years Active

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Basic Information

Product Code: EBH
Device Class: FDA class 1
Regulation Number: 872.3670
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 30 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K933745	PERMAGEN UNIVERSAL BONDING RESIN	Jan 26, 1994	Substantially Equivalent	Bio-Systems Research
K930487	PALATRAY LC MINT	Jun 18, 1993	Substantially Equivalent	Heraeus Kulzer, Inc.
K923979	LC TRAY MATERIAL	Nov 17, 1992	Substantially Equivalent	Dentsply Intl.
K923549	PALADISC LC	Sep 29, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K912820	POLYESTER RESIN HAND MOLDED TRAY	Aug 21, 1991	Substantially Equivalent	E&D Dental Products, Inc.
K905058	PALAVIT L	Jun 06, 1991	Substantially Equivalent	Kulzer, Inc.
K902350	PALATRAY LC RESIN IMPRESSION TRAY MATERIAL	Jul 26, 1990	Substantially Equivalent	Kulzer, Inc.
K901782	CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM	Jun 29, 1990	Substantially Equivalent	Productivity Training Corp.
K890712	ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS	Apr 25, 1989	Substantially Equivalent	Advantage Dental Products, Inc.
K881838	MODIFIED PERMAGUM ADHESIVE	Jul 27, 1988	Substantially Equivalent	Espe GmbH (Us)
K875257	IMPREGUM F ADHESIVE	Mar 09, 1988	Substantially Equivalent	Espe GmbH (Us)
K875228	PERMADYNE ADHESIVE	Mar 09, 1988	Substantially Equivalent	Espe GmbH (Us)
K873739	ACRYLIC IMPRESSION TRAY MATERIALS	Mar 07, 1988	Substantially Equivalent	E&D Dental Manufacturing Co.
K872210	IMPRESSION TRAY	Jun 22, 1987	Substantially Equivalent	Dentsply Intl.
K863421	SR-IVOLEN TRAY MATERIAL	Nov 03, 1986	Substantially Equivalent	Ivoclar USA, Inc.
K854042	RESIN TRAY IMPRESSION MATERIAL	Nov 07, 1985	Substantially Equivalent	Dentsply Intl.
K853093	PSP TEMP - TRAY	Sep 06, 1985	Substantially Equivalent	Psp Dental Co., Ltd.
K852182	EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER	Jul 02, 1985	Substantially Equivalent	The S. S. White Co.
K844471	VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE	Feb 08, 1985	Substantially Equivalent	Dentsply Intl.
K850014	HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE	Jan 23, 1985	Substantially Equivalent	Medi-Dent American, Inc.
K831293	SOLARCRYL CUSTOM TRAY MATERIAL	Jul 26, 1983	Substantially Equivalent	Solar Dental Co., Inc.
K820998	DENTRON-DIRECT-TRAY	Jun 10, 1982	Substantially Equivalent	Dentron, Inc.
K820997	DENTRON-EXACT - TRAY	Jun 10, 1982	Substantially Equivalent	Dentron, Inc.
K813550	HYBRID DENTAL PRODUCT	Feb 24, 1982	Substantially Equivalent	Dentsply Intl.
K810686	SR-IVOLEN	Apr 14, 1981	Substantially Equivalent	J. Aderer, Inc.
K802751	P-10 POSTERIOR FILLING MATERIAL	Nov 12, 1980	Substantially Equivalent	3M Company
K801780	OXY CUSTOM TRAY RESIN	Aug 07, 1980	Substantially Equivalent	Oxy Dental Products, Inc.
K790897	QUAD IV CUSTOM IMPRESSION TRAY	Jun 15, 1979	Substantially Equivalent	Sted, Inc.
K782153	IMPRESSION TRAY, MDDS CUSTOM	Feb 26, 1979	Substantially Equivalent	Chayet and Sonnenrich, P.C.
K760754	CUTTER TRAY-ACRYLIC FOR IMP TRAYS	Oct 15, 1976	Substantially Equivalent	Cutter Laboratories, Inc.