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Parkell®

Mixing Tip 3

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000526977
Basic UDI-DI: 081000052MIXINGTIP3JZ
Reference: S439IOT
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Application Tips

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000526960
Basic UDI-DI: 081000052NEEDLETIP4ZK
Reference: S383
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Mixing/Dispensing Tips

Class IMDR 2017/745No longer on the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000526861
Basic UDI-DI: 081000052MIXINGTIPWR
Reference: S302
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Mixing Tip 4

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000526854
Basic UDI-DI: 081000052MIXINGTIP4K3
Reference: S292
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Mixing Tip 2

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000526847
Basic UDI-DI: 081000052MIXINGTIP2JX
Reference: S275
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Pre-Bent Needle Tip

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000526830
Basic UDI-DI: 081000052NEEDLETIP2ZF
Reference: S390
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Luer Lock Applicator Tips

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000526809
Basic UDI-DI: 081000052NEEDLETIP3ZH
Reference: S181
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Henry Schein

TF-121

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Henry Schein Inc.
Manufacturer SRN: US-MF-000021683
UDI-DI: H65890030491
Basic UDI-DI: 03040412101AX
Reference: 9003049
EMDN: Q019001
EMDN description: SALIVA ASPIRATORS AND SALIVA ABSORBENTS
First on market country: Germany
Authorised representative: Henry Schein Services GmbH
Last updated: 15.07.2026 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

Henry Schein

TF-448 (HS)

Class IMDR 2017/745On the marketReprocessedSingle use

Manufacturer: Henry Schein Inc.
Manufacturer SRN: US-MF-000021683
UDI-DI: 10304040132217
Basic UDI-DI: 03040444801DH
Reference: 5702048
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Henry Schein Services GmbH
Last updated: 15.07.2026 23:20

Manufacturer products Authorised representative products Authorised representative actors View details

Henry Schein

TF-170 (HS)

Class IMDR 2017/745On the marketContains latexReprocessedSingle use

Manufacturer: Henry Schein Inc.
Manufacturer SRN: US-MF-000021683
UDI-DI: 10304040090982
Basic UDI-DI: 03040417001BV
Reference: 9002650
EMDN: Q019002
EMDN description: DENTISTRY DAMS AND HOOKS, SINGLE-USE
First on market country: Germany
Authorised representative: Henry Schein Services GmbH
Last updated: 15.07.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Henry Schein

TF-372(HS)

Class IMDR 2017/745On the marketContains latexReprocessedSingle use

Manufacturer: Henry Schein Inc.
Manufacturer SRN: US-MF-000021683
UDI-DI: 10304040082024
Basic UDI-DI: 03040437201CV
Reference: 5701622
EMDN: Q019002
EMDN description: DENTISTRY DAMS AND HOOKS, SINGLE-USE
First on market country: Germany
Authorised representative: Henry Schein Services GmbH
Last updated: 15.07.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Trace disclosing solution 2oz.

Plaque Dislcosing Products

Class IMDR 2017/745On the marketSingle use

Manufacturer: Young Dental Manufacturing I, LLC
Manufacturer SRN: US-MF-000027132
UDI-DI: 10302732311025
Basic UDI-DI: 03027360408D530780QJCSZ
Reference: 231102
EMDN: Q019003
EMDN description: DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE)
First on market country: Germany
Authorised representative: Young Microbrush Ireland Ltd
Last updated: 15.07.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Cotons salivaires N°3 -Pasteur /40x150

Dentaire

Class IMDR 2017/745On the marketSingle use

Manufacturer: MEDISTOCK
Manufacturer SRN: FR-MF-000007667
UDI-DI: 03700425932494
Basic UDI-DI: 03700425NS-classI-004W7
Reference: H8003P
EMDN: Q019004
EMDN description: DENTAL COTTON ROLLS
First on market country: France
Authorised representative: -
Last updated: 15.07.2026 23:15

Manufacturer products View details

Micros applicateurs standard vert /4800

Embout

Class IMDR 2017/745On the marketSingle use

Manufacturer: MEDISTOCK
Manufacturer SRN: FR-MF-000007667
UDI-DI: 03700425908819
Basic UDI-DI: 03700425NS-classI-007WD
Reference: K50031G
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: France
Authorised representative: -
Last updated: 15.07.2026 23:15

Manufacturer products View details

HybenX® OTD Gel

HYBENX OTD – 2 pack – 103-5002

Class IMDR 2017/745On the marketSingle use

Manufacturer: EPIEN Medical, Inc
Manufacturer SRN: US-MF-000008278
UDI-DI: 00860004740322
Basic UDI-DI: 03629421035002GA
Reference: 103-5002
EMDN: Q019007
EMDN description: BUCCAL TOPICAL TREATMENT PREPARATIONS NOT INCLUDED IN OTHER CLASSES
First on market country: Netherlands
Authorised representative: QNET B.V.
Last updated: 15.07.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

HybenX® OTD

103-2001

Class IMDR 2017/745On the marketSingle use

Manufacturer: EPIEN Medical, Inc
Manufacturer SRN: US-MF-000008278
UDI-DI: 00860004740315
Basic UDI-DI: 03629421032001FK
Reference: 103-2001
EMDN: Q019007
EMDN description: BUCCAL TOPICAL TREATMENT PREPARATIONS NOT INCLUDED IN OTHER CLASSES
First on market country: Netherlands
Authorised representative: QNET B.V.
Last updated: 15.07.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

00362942000020

Oralmedic

Class IMDR 2017/745On the marketSingle use

Manufacturer: EPIEN Medical, Inc
Manufacturer SRN: US-MF-000008278
UDI-DI: 00362942000020
Basic UDI-DI: 03629421050003FX
Reference: 105-0005
EMDN: Q019007
EMDN description: BUCCAL TOPICAL TREATMENT PREPARATIONS NOT INCLUDED IN OTHER CLASSES
First on market country: Netherlands
Authorised representative: QNET B.V.
Last updated: 15.07.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

Oratip Adapter

Miscellaneous Class I Dental Accessories

Class IMDR 2017/745On the market

Manufacturer: Pascal Company Inc.
Manufacturer SRN: US-MF-000032036
UDI-DI: 00310866000121
Basic UDI-DI: 03108666001GS
Reference: 24080
EMDN: Q019001
EMDN description: SALIVA ASPIRATORS AND SALIVA ABSORBENTS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Henry Schein

TF-109 (HS)

Class IMDR 2017/745On the marketSingle use

Manufacturer: Henry Schein Inc.
Manufacturer SRN: US-MF-000021683
UDI-DI: 00304040098998
Basic UDI-DI: 03040410901BR
Reference: 9001895
EMDN: Q019004
EMDN description: DENTAL COTTON ROLLS
First on market country: Germany
Authorised representative: Henry Schein Services GmbH
Last updated: 15.07.2026 23:12

Manufacturer products Authorised representative products Authorised representative actors View details

Henry Schein

TF-424 (HS)

Class IMDR 2017/745On the market

Manufacturer: Henry Schein Inc.
Manufacturer SRN: US-MF-000021683
UDI-DI: 00304040053881
Basic UDI-DI: 03040442401CF
Reference: 9883134
EMDN: Q019003
EMDN description: DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE)
First on market country: Germany
Authorised representative: Henry Schein Services GmbH
Last updated: 15.07.2026 23:12

Manufacturer products Authorised representative products Authorised representative actors View details