ROEKO RoekoSeal Automix

FDA UDI

Class II (US FDA UDI)

by Coltène/Whaledent AG

Identity

Trade Name: ROEKO RoekoSeal Automix FDA UDI
Generic Name: Endodontic filling/sealing material FDA UDI
Model / Reference: Set FDA UDI

Identifiers

Catalog Number: 349100 FDA UDI
Primary DI / UDI-DI: E1653491000 FDA UDI
510(k) Number: K983037 FDA UDI
FDA Product Code: KIF FDA UDI
GMDN Term: Endodontic filling/sealing material FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3820 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

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

ROEKO RoekoSeal Automix by Coltène/Whaledent AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

K983037 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Coltène/Whaledent AG

Sources (1)

FDA UDI fd196c12-cc26-4cc3-a8c0-2bf57f57f90d 36 fields · synced May 29, 2026