Ah 26

FDA UDI

Class II (US FDA UDI)

by Dentsply De Trey GmbH

Identity

Trade Name: AH 26 FDA UDI
Generic Name: Endodontic filling/sealing material FDA UDI
Device Name: AH 26 Refill is a 2 component powder/resin root canal filling material consisting of a powder jar (D010K3019010) and a resin tube (D010K3019120) FDA UDI
Model / Reference: 60620101 FDA UDI
Description: AH 26 Refill is a 2 component powder/resin root canal filling material consisting of a powder jar (D010K3019010) and a resin tube (D010K3019120) FDA UDI

Identifiers

Catalog Number: 60620101 FDA UDI
Primary DI / UDI-DI: D010606201011 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 8 Gram FDA UDI
Weight — 10 Gram FDA UDI

Category: Endodontic filling/sealing material

Ah 26 by Dentsply De Trey GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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DIA-ROOT BIO Sealer — DiaDent Group International · Class II

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: Dentsply De Trey GmbH

Sources (1)

FDA UDI 4d8a9e1a-fe30-475e-9426-67afc8d900e3 36 fields · synced Jun 8, 2026