Product Code: EIE FDA class 1 21 CFR 872.6300

Dam, Rubber

Dental

The Rubber Dam is a thin, flexible sheet of latex or non-latex material stretched across a metal frame and clamped around a tooth or teeth to isolate the operative field from saliva, blood, and oral bacteria during restorative, endodontic, or other dental procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EIE, regulated under 21 CFR 872.6300 in the Dental (DE) specialty. This device is exempt from GMP requirements.

View on FDA

510(k)s

FEI Numbers

110

Registration Numbers

110

Unique Applicants

Years Active

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Basic Information

Product Code: EIE
Device Class: FDA class 1
Regulation Number: 872.6300
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 33 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K182118	armor LC	May 03, 2019	Substantially Equivalent	Mavrik Dental Systems, Ltd.
K151945	Triumph Resin Dam	Feb 18, 2016	Substantially Equivalent	Denali Corporation
K050318	BARI-KAD PACKING DEVICE	Mar 04, 2005	Substantially Equivalent	Bioenvelop Agro, Inc.
K043301	GC TION GINGIVAL PROTECTOR	Jan 25, 2005	Substantially Equivalent	GC America, Inc.
K040797	BRITESMILE MASKING CREAM	Apr 02, 2004	Substantially Equivalent	Britesmile, Inc.
K022522	PULPDENT PUTTY DAM	Sep 26, 2002	Substantially Equivalent	Pulpdent Corporation
K021524	LIGHT CURE DENTAL DAM	Jul 19, 2002	Substantially Equivalent	Prime Dental Manufacturing, Inc.
K021613	NIVEOUS LIQUID DAM	Jun 20, 2002	Substantially Equivalent	Shofu Dental Corp.
K010935	BRITESMILE BARRIER MATERIAL	Sep 05, 2001	Substantially Equivalent	Britesmile, Inc.
K983227	POWER BLOCK	Dec 11, 1998	Substantially Equivalent	Kreativ, Inc.
K972775	FASTDAM	Feb 27, 1998	Substantially Equivalent	Interdent, Inc.
K961472	DENTAL DAM SILICONE	Aug 07, 1996	Substantially Equivalent	Worldwide Dental, Inc.
K954990	DENTAL DAM	Jan 26, 1996	Substantially Equivalent	The Hygenic Corp.
K952628	ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS	Oct 19, 1995	Substantially Equivalent	Elastomade Accessories Sdn Bhd
K942992	ROYAL SHIELD RUBBER DAMS	Sep 21, 1994	Substantially Equivalent	Elastomade Accessories Sdn Bhd
K923157	DENTAL RUBBER DAM	Jul 22, 1993	Substantially Equivalent	Aseptico, Inc.
K923163	RUBBER DAM CLAMP	Dec 28, 1992	Substantially Equivalent	Aseptico, Inc.
K921771	MINIDAM II	Sep 17, 1992	Substantially Equivalent	Delsan Dental Systems
K905470	STANDARD RUBBER DAM WITH OR WITHOUT FRAMES	Apr 25, 1991	Substantially Equivalent	Elastomade Accessories Sdn Bhd
K901236	RUBBER, DENTAL DAM (NON-STERILE)	Jun 06, 1990	Substantially Equivalent	Naturub Sdn. Bhd.
K900844	WEDJETS	Apr 16, 1990	Substantially Equivalent	The Hygenic Corp.
K894120	MADEGOM LTDA. DENTAL DAM	Aug 21, 1989	Substantially Equivalent	Madegom
K885231	KITCHIN DENTAL ABCESS DRAIN	May 16, 1989	Substantially Equivalent	Kitchin, Inc.
K890667	RUBBER DAM	Mar 29, 1989	Substantially Equivalent	Cost Rite Health Products, Inc.
K884828	HANDIDAM	Feb 03, 1989	Substantially Equivalent	Aseptico, Inc.
K875255	DREAM DAM	Mar 18, 1988	Substantially Equivalent	Dental Dam, Inc.
K864096	DREAM DAM	Nov 18, 1986	Substantially Equivalent	Dental Dam, Inc.
K863816	IVORY PREMIUM RUBBER DAM	Oct 27, 1986	Substantially Equivalent	Columbus Dental Mfg. Co.
K852630	DEN-MAT PAINT-ON RUBBER DAM	Dec 18, 1985	Substantially Equivalent	Den-Mat Corp.
K851045	DENT-DR. VACU-FRAME	Apr 22, 1985	Substantially Equivalent	Dent-Dr.
K842844	DENTI-D RUBBER DAM	Aug 17, 1984	Substantially Equivalent	Fema Corp.
K833610	DENTAL RUBBERDAM	Jan 10, 1984	Substantially Equivalent	Center For Marketing Services
K780745	RUBBER DAM	May 12, 1978	Substantially Equivalent	Hygienic Dental Mfg., Co., The