GuttaCore for WaveOne Gold

FDA UDI

Class I (US FDA UDI)

by Tulsa Dental Products Llc

Identity

Trade Name: GuttaCore for WaveOne Gold FDA UDI
Generic Name: Manual endodontic file/rasp, reusable FDA UDI
Device Name: GuttaCore for W1g Size Verifier LRG FDA UDI
Model / Reference: TNSGCWG625LRG FDA UDI
Description: GuttaCore for W1g Size Verifier LRG FDA UDI

Identifiers

Catalog Number: TNSGCWG625LRG FDA UDI
Primary DI / UDI-DI: D716TNSGCWG625LRG1 FDA UDI
FDA Product Code: EIL FDA UDI
GMDN Term: Manual endodontic file/rasp, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual endodontic file/rasp, reusable

GuttaCore for WaveOne Gold by Tulsa Dental Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Tulsa Dental Products Llc

Sources (1)

FDA UDI d97640aa-159b-4eb7-a600-6fd6c219bfef 34 fields · synced May 31, 2026