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Dia-Kondensor

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 551-103

by DiaDent Group International

Identity

Trade Name
DIA-KONDENSOR #50/100 EUDAMED
DIA-KONDENSOR FDA UDI
Generic Name
Endodontic filling material condenser FDA UDI
Device Name
DIA-KONDENSOR EUDAMED
DIA-KONDENSOR is having both a nIckel-titanium end a stainless steel end, it can be used in any common endodontic obturation technique including warm and cold condensation. FDA UDI
Model / Reference
551-103 EUDAMED
#50/100 FDA UDI
Description
DIA-KONDENSOR is having both a nIckel-titanium end a stainless steel end, it can be used in any common endodontic obturation technique including warm and cold condensation. FDA UDI

Identifiers

Catalog Number
551-103 FDA UDI
Primary DI / UDI-DI
08806383545815 EUDAMEDFDA UDI
Basic UDI-DI
88063835EFMCU2 EUDAMED
FDA Product Code
DZA FDA UDI
EMDN Code
L15900699 DENTAL MATERIAL PROCESSING INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term
Endodontic filling material condenser FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
872.4130 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Endodontic filling material condenser

Dia-Kondensor by DiaDent Group International — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Endodontic filling material condenser.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Sources (2)

  • FDA UDI 7e38ab5d-3bdb-44e9-8f71-ac042dd2c055 34 fields · synced Jul 26, 2026
  • EUDAMED 17625038-942b-42a9-95be-6242ecf4d044 61 fields · synced Jul 26, 2026