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Parkell®

Beavertail 30k Internal Water Scaler

Class IIaMDDNo longer on the market

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000522514
Basic UDI-DI: B-00810000522514
Reference: DBI30
EMDN: Z12119001
EMDN description: TARTAR ABLATORS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 01.08.2026 10:13

Manufacturer products Authorised representative products Authorised representative actors View details

TurboSENSOR +™

D660-P

Class IIaMDDNo longer on the marketActive device

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000521067
Basic UDI-DI: B-00810000521067
Reference: D660-P
EMDN: Z12119001
EMDN description: TARTAR ABLATORS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 01.08.2026 10:13

Manufacturer products Authorised representative products Authorised representative actors View details

TurboSENSOR +™

D660-O

Class IIaMDDNo longer on the marketActive device

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000521050
Basic UDI-DI: B-00810000521050
Reference: D660-O
EMDN: Z12119001
EMDN description: TARTAR ABLATORS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 01.08.2026 10:13

Manufacturer products Authorised representative products Authorised representative actors View details

TurboSENSOR +™

D660-N

Class IIaMDDNo longer on the marketActive device

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000521043
Basic UDI-DI: B-00810000521043
Reference: D660-N
EMDN: Z12119001
EMDN description: TARTAR ABLATORS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 01.08.2026 10:13

Manufacturer products Authorised representative products Authorised representative actors View details

TurboSENSOR +™

D660-B

Class IIaMDDNo longer on the marketActive device

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000521036
Basic UDI-DI: B-00810000521036
Reference: D660-B
EMDN: Z12119001
EMDN description: TARTAR ABLATORS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 01.08.2026 10:13

Manufacturer products Authorised representative products Authorised representative actors View details

TurboSENSOR +™

D660

Class IIaMDDNo longer on the marketActive device

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000520985
Basic UDI-DI: B-00810000520985
Reference: D660
EMDN: Z12119001
EMDN description: TARTAR ABLATORS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 01.08.2026 10:13

Manufacturer products Authorised representative products Authorised representative actors View details

TurboSENSOR +™

D722

Class IIaMDDOn the marketActive device

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000520909
Basic UDI-DI: B-00810000520909
Reference: D722
EMDN: Z12119001
EMDN description: TARTAR ABLATORS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 01.08.2026 10:13

Manufacturer products Authorised representative products Authorised representative actors View details

Digitest™

Digitest 3

Class IIaMDDOn the marketActive device

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000520862
Basic UDI-DI: B-00810000520862
Reference: D655
EMDN: Z12119005
EMDN description: PULP VITALITY ANALYSERS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 01.08.2026 10:13

Manufacturer products Authorised representative products Authorised representative actors View details

Digitest™

D655E

Class IIaMDDOn the marketActive device

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000520688
Basic UDI-DI: B-00810000520688
Reference: D655E
EMDN: Z12119005
EMDN description: PULP VITALITY ANALYSERS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 01.08.2026 10:12

Manufacturer products Authorised representative products Authorised representative actors View details

TurboSENSOR®

TurboSENSOR

Class IIaMDDNo longer on the marketActive device

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000520527
Basic UDI-DI: B-00810000520527
Reference: D560-230
EMDN: Z12119001
EMDN description: TARTAR ABLATORS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 01.08.2026 10:12

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Precision Probe Set

Class IIaMDDOn the market

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000520480
Basic UDI-DI: B-00810000520480
Reference: D636
EMDN: Z12119005
EMDN description: PULP VITALITY ANALYSERS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 01.08.2026 10:12

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Ground Clip and Lead Wire

Class IIaMDDOn the market

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000520473
Basic UDI-DI: B-00810000520473
Reference: D631GC
EMDN: Z12119005
EMDN description: PULP VITALITY ANALYSERS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 01.08.2026 10:12

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Metal Probes

Class IIaMDDOn the market

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000520459
Basic UDI-DI: B-00810000520459
Reference: D625
EMDN: Z12119005
EMDN description: PULP VITALITY ANALYSERS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 01.08.2026 10:12

Manufacturer products Authorised representative products Authorised representative actors View details

Implantmed

SI-923

Class IIaMDDNo longer on the marketActive device

Manufacturer: W&H Dentalwerk Bürmoos GmbH
Manufacturer SRN: AT-MF-000001590
UDI-DI: +J021169290001
Basic UDI-DI: B-+J021169290001
Reference: 16929000
EMDN: Z12119099
EMDN description: VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 01.08.2026 03:41

Manufacturer products View details

S-11

Class IIaMDDNo longer on the marketActive deviceReusable

Manufacturer: W&H Dentalwerk Bürmoos GmbH
Manufacturer SRN: AT-MF-000001590
UDI-DI: +J021000011001
Basic UDI-DI: B-+J021000011001
Reference: 00001100
EMDN: Z12119099
EMDN description: VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 01.08.2026 03:41

Manufacturer products View details

KaVo ProXam iCam

Intraoral Camera

Class IMDR 2017/745On the marketActive device

Manufacturer: DENTALL Co., Ltd.
Manufacturer SRN: KR-MF-000013640
UDI-DI: ++D1332023800082
Basic UDI-DI: 88000969IOC01LG
Reference: 2023800082
EMDN: Z12119080
EMDN description: VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 23:56

Manufacturer products Authorised representative products Authorised representative actors View details

04589551389001

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Nakanishi Inc.
Manufacturer SRN: JP-MF-000011271
UDI-DI: 04589551389001
Basic UDI-DI: 45602249800002177C
Reference: 10000977
EMDN: Z12119080
EMDN description: VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: NSK Europe GmbH
Last updated: 31.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

04589551388936

Class IMDR 2017/745On the market

Manufacturer: Nakanishi Inc.
Manufacturer SRN: JP-MF-000011271
UDI-DI: 04589551388936
Basic UDI-DI: 45602249800001277A
Reference: E350056
EMDN: Z12119080
EMDN description: VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: NSK Europe GmbH
Last updated: 31.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

AKOS

Dental Low Speed Handpiece

Class IIaMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: FOSHAN AKOS MEDICAL INSTRUMENT CO., LTD
Manufacturer SRN: CN-MF-000030891
UDI-DI: 06975399563204
Basic UDI-DI: 697539956954T
Reference: X95L-3
EMDN: Z12119006
EMDN description: DENTAL CLEANING/WASHING HANDPIECE EQUIPMENTS
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:44

Manufacturer products Authorised representative products Authorised representative actors View details

Ultrasonic Scaler Handpiece

HP-3H, HP-5L, HS-7H, HS-7L, HY-2L

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Guilin Refine Medical Instrument Co.,Ltd.
Manufacturer SRN: CN-MF-000012204
UDI-DI: 06971560450373
Basic UDI-DI: 697156045USHTX
Reference: HP-3H
EMDN: Z12119006
EMDN description: DENTAL CLEANING/WASHING HANDPIECE EQUIPMENTS
First on market country: Austria
Authorised representative: MedNet EC-REP C IIb GmbH
Last updated: 31.07.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details