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Gentle Pulse™

FDA UDI

Class II (US FDA UDI)

by Parkell, Inc.

Identity

Trade Name
Gentle Pulse™ FDA UDI
Generic Name
Dental pulp analysis system FDA UDI
Device Name
Metal Probes for Gentle Pulse™ & Digitest™ Pulptesters (1-Short & 1-Long)(Korea) FDA UDI
Model / Reference
D625-K FDA UDI
Description
Metal Probes for Gentle Pulse™ & Digitest™ Pulptesters (1-Short & 1-Long)(Korea) FDA UDI

Identifiers

Catalog Number
D625-K FDA UDI
Primary DI / UDI-DI
00810000520961 FDA UDI
FDA Product Code
EAT FDA UDI
GMDN Term
Dental pulp analysis system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.1720 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental pulp analysis system

Gentle Pulse™ by Parkell, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental pulp analysis system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Parkell, Inc.

Sources (1)

  • FDA UDI 0fa65473-d5a5-4792-b73b-ca432f1180c1 35 fields · synced May 30, 2026