Identifiers
- 510(k) Number
- K950238 FDA 510(k)
- FDA Product Code
- EAT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.1720 FDA 510(k)
- Regulation Number
- 872.1720 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Gental Pulse Pulp Vitality Tester is a dental diagnostic device classified as a Tester, Pulp under FDA classification EAT. It evaluates tooth vitality by delivering a controlled electrical stimulus to assess patient response, distinguishing between living and non-living dental pulp.
This hand-held, battery-powered device is intended for use in dental offices and is regulated under FDA 510(k) clearance (K950238). It operates as a single-use or reusable diagnostic tool, adhering to regulatory standards for dental instruments (regulation number 872.1720). No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What is the primary purpose of the Gental Pulse Pulp Vitality Tester and how does it work in a clinical setting?
The Gental Pulse Pulp Vitality Tester is designed to evaluate tooth vitality by delivering a controlled electrical stimulus to assess a patient’s response. This helps clinicians distinguish between living and non-living dental pulp, aiding in diagnostic decisions like determining the need for root canal therapy or other dental interventions. It’s a handheld, battery-powered device used exclusively in dental offices.
Is the Gental Pulse Pulp Vitality Tester intended for single-use or can it be reused?
The Gental Pulse Pulp Vitality Tester is explicitly labeled as a device that can be used either as a single-use or reusable tool, depending on clinical practice and infection control protocols. There are no specific sterility requirements mentioned in the data, so proper cleaning and sterilization procedures must be followed if reused.
What regulatory pathway was followed for FDA clearance of the Gental Pulse Pulp Vitality Tester?
The Gental Pulse Pulp Vitality Tester received FDA clearance through a Traditional 510(k) pathway, classified under Product Code EAT (Tester, Pulp). It was determined to be Substantially Equivalent to a predicate device and was reviewed by the Dental (DE) Advisory Committee. The clearance number is K950238, and the device adheres to FDA regulation 872.1720 for dental instruments.
Are there multiple models or variations of the Gental Pulse Pulp Vitality Tester available?
Yes, the Gental Pulse Pulp Vitality Tester comes in multiple FEI (Final Establishment Identification) numbers, indicating different lot or model variations. These include identifiers like 3010862763, 3038718579, 3004425647, and others, suggesting potential differences in batch or configuration. However, the core functionality remains consistent across all listed variations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GENTAL PULSE (K950238) — FDA 510 (k) | Innolitics, Pulp vitality tester - Gentle Pulse™ - Parkell Inc. - MedicalExpo, PDF A00095_revK0424_GentlePulse ifu EN-FR - Parkell, Gentle Pulse Analog Pulp Vitality Tester- Parkell (D624MS)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K950238 | Class II | Active |
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Manufacturer
- Manufacturer
- Parkell, Inc.
Sources (1)
- FDA 510(k) K950238 24 fields · synced Sep 19, 2026