Edta Solution, 17%

FDA UDI

Class I (US FDA UDI)

by Pulpdent Corporation

Identity

Trade Name: EDTA SOLUTION, 17% FDA UDI
Generic Name: Endodontic reaming aid material FDA UDI
Device Name: 30 mL bottle FDA UDI
Model / Reference: EDTA30 FDA UDI
Description: 30 mL bottle FDA UDI

Identifiers

Primary DI / UDI-DI: D701EDTA302 FDA UDI
FDA Product Code: EKL FDA UDI
GMDN Term: Endodontic reaming aid material FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3840 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 30 Milliliter FDA UDI

Category: Endodontic reaming aid material

Edta Solution, 17% by Pulpdent Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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RC-Prep — PREMIER DENTAL PRODUCTS COMPANY · Class I
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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Pulpdent Corporation

Sources (1)

FDA UDI ea6b785b-756c-47e9-afec-490d12cc7b66 34 fields · synced Jun 9, 2026