HYGENIC® GuttaFlow®2

FDA UDI

Class I (US FDA UDI)

by Coltène/Whaledent AG

Identity

Trade Name: HYGENIC® GuttaFlow®2 FDA UDI
Generic Name: Endodontic filling/sealing material FDA UDI
Device Name: The HYGENIC® GuttaFlow®2 Introkit contains 1 x Capsules GuttaFlow®2 (20 pcs), 1 x Canal Tips + Stops (20 pcs), 1 x Adapters for RotoMix™( 3 pcs), 1 x Dispenser, 1 x HYGENIC® Gutta Percha Points ISO 15-40 sample (100 pcs) and 1 x HYGENIC® Spectra Point® Gutta Percha Points Greater Taper 0.04 20-45 sample (60 pcs). FDA UDI
Model / Reference: INTROKIT FDA UDI
Description: The HYGENIC® GuttaFlow®2 Introkit contains 1 x Capsules GuttaFlow®2 (20 pcs), 1 x Canal Tips + Stops (20 pcs), 1 x Adapters for RotoMix™( 3 pcs), 1 x Dispenser, 1 x HYGENIC® Gutta Percha Points ISO 15-40 sample (100 pcs) and 1 x HYGENIC® Spectra Point® Gutta Percha Points Greater Taper 0.04 20-45 sample (60 pcs). FDA UDI

Identifiers

Catalog Number: 60013710 FDA UDI
Primary DI / UDI-DI: E165600137100 FDA UDI
510(k) Number: K032662 FDA UDI
FDA Product Code: EKM FDA UDI
KIF FDA UDI
GMDN Term: Endodontic filling/sealing material FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3850 FDA UDI
872.3820 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Category: Endodontic filling/sealing material

HYGENIC® GuttaFlow®2 by Coltène/Whaledent AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Endodontic filling/sealing material.

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GIBSON — BENCO DENTAL SUPPLY CO. · Class II
Midway Select — MIDWAY DENTAL SUPPLY, LLC · Class I
DIA-ROOT BIO Sealer — DiaDent Group International · Class II
Henry Schein — HENRY SCHEIN, INC. · Class II

Cleared under the same submission

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: Coltène/Whaledent AG

Sources (1)

FDA UDI fda710e6-1880-4d1b-9e83-24e9b48dc5bd 37 fields · synced Jun 8, 2026