Product Code: EAT FDA class 2 21 CFR 872.1720

Tester, Pulp

Dental

The Pulp Tester is a dental diagnostic device that delivers a controlled electrical or thermal stimulus to a tooth to assess the vitality and sensory responsiveness of the dental pulp, aiding in diagnosis of pulpal conditions. It is classified as FDA Class 2, indicating moderate risk; however, it does not require a premarket submission under the applicable exemption provisions. The product code is EAT and the applicable regulation is 21 CFR 872.1720, under the Dental medical specialty.

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510(k)s

FEI Numbers

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Basic Information

Product Code: EAT
Device Class: FDA class 2
Regulation Number: 872.1720
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 22 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K022097	THERMIQUE	Sep 06, 2002	Substantially Equivalent	Parkell, Inc.
K021298	ELEMENTS DIAGNOSTIC UNIT	Jun 19, 2002	Substantially Equivalent	Sybron Endo/Analytic
K012427	PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT	Oct 09, 2001	Substantially Equivalent	Specialites Septodont
K011666	CHILLIT	Aug 06, 2001	Substantially Equivalent	Heatshield, Inc.
K990225	ENDO ANALYZER, MODEL 8005, MODIFIED	Feb 25, 1999	Substantially Equivalent	Sybron Dental Specialties, Inc.
K973439	ENDO ANALYZER, MODEL 8005	Dec 08, 1997	Substantially Equivalent	Sybron Dental Specialties, Inc.
K970715	SYSTEM B HEAT SOURCE	Apr 07, 1997	Substantially Equivalent	Sybron Dental Specialties, Inc.
K963862	TOUCH N' HEAT	Dec 02, 1996	Substantially Equivalent	Sybron Dental Specialties, Inc.
K960799	ORTHO-ICE	May 09, 1996	Substantially Equivalent	Ultimate Wireforms, Inc.
K950237	DIGITEST	Jun 09, 1995	Substantially Equivalent	Parkell, Inc.
K950238	GENTAL PULSE	May 09, 1995	Substantially Equivalent	Parkell, Inc.
K940260	THERMAL PULP TESTER	Mar 07, 1994	Substantially Equivalent	Union Broach, Div. Moyco Industries, Inc.
K930764	ENDO-ICE-PULP TESTER-THERMAL	May 27, 1993	Substantially Equivalent	The Hygenic Corp.
K883804	E-MITT (CONDUCTIVE HAND COVER)	Jul 31, 1989	Substantially Equivalent	The Institute For Technology Development
K881826	ENDO-ICE	Aug 23, 1988	Substantially Equivalent for Some Indications	The Hygenic Corp.
K872039	MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS	Nov 13, 1987	Substantially Equivalent	Life-Tech Intl., Inc.
K873644	PULP PEN	Oct 27, 1987	Substantially Equivalent	The Hygenic Corp.
K870118	MODEL 6110B DENTAPHOR	Apr 10, 1987	Substantially Equivalent	Life-Tech Intl., Inc.
K830105	VITATHYL	Mar 01, 1983	Substantially Equivalent	North Pacific Dental, Inc.
K820598	HOT & COLD PULP TESTER #4001	Mar 19, 1982	Substantially Equivalent	Analytic Technology
K800138	TS-301 THREE-WAY PULP TESTER	Feb 13, 1980	Substantially Equivalent	Tamler-Stoneham Instruments
K790799	PULPTESTER MODEL 2001	May 31, 1979	Substantially Equivalent	Analytic Technology