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Parkell®
EUDAMEDFDA UDIClass I (EU MDR)
Ref S535Ref S545Ref S329Ref DSG30PRef DORING-BLRef DUI25
by Parkell Inc.
Identity
- Trade Name
- Parkell® EUDAMEDFDA UDIHyperFIL™ FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDIDental material injection cannula, single-use FDA UDI
- Device Name
- Mixing Tip 5 EUDAMEDMixing/Dispensing Tips EUDAMEDSoft-Grip Perio 30k Internal Water Ultrasonic Scaler Tip EUDAMEDFDA UDIUniversal 25k Internal Water Scaler Insert EUDAMEDFDA UDIO-Ring EUDAMEDBlack O-Rings for 25k Scaler Insert (Pkg. of 12 pcs.) FDA UDIWhite Intraoral Tip for Use on S328 Mixing Tip (Pkg. of 50 pcs.) FDA UDI
- Model / Reference
- S535 EUDAMEDS545 EUDAMEDS329 EUDAMEDFDA UDIDSG30P EUDAMEDFDA UDIDUI25 EUDAMEDFDA UDIDORING-BL EUDAMEDFDA UDI
- Description
- Soft-Grip Perio 30k Internal Water Ultrasonic Scaler Tip FDA UDIUniversal 25k Internal Water Scaler Insert FDA UDIBlack O-Rings for 25k Scaler Insert (Pkg. of 12 pcs.) FDA UDIWhite Intraoral Tip for Use on S328 Mixing Tip (Pkg. of 50 pcs.) FDA UDI
Identifiers
- Catalog Number
- DSG30P FDA UDIDUI25 FDA UDIDORING-BL FDA UDIS329 FDA UDI
- Primary DI / UDI-DI
- 10810000528285 EUDAMED10810000528308 EUDAMED10810000526915 EUDAMEDFDA UDI00810000522798 EUDAMEDFDA UDI00810000522880 EUDAMEDFDA UDI10810000522634 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000052MIXINGTIP5K5 EUDAMED081000052MIXINGTIPWR EUDAMEDB-00810000522798 EUDAMED081000052ORINGUT EUDAMEDB-00810000522880 EUDAMED
- Unit of Use DI
- 00810000528295 EUDAMED00810000528301 EUDAMED00810000526918 EUDAMED00810000522637 EUDAMED
- FDA Product Code
- ELC FDA UDIEBF FDA UDI
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMEDZ12119001 TARTAR ABLATORS EUDAMED
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDIDental material injection cannula, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4850 FDA UDI872.3690 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDIFDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental material injection cannula, single-use
Parkell® by Parkell, Inc. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental material injection cannula, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 081000052MIXINGTIP5K5 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 081000052MIXINGTIP5K5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Parkell Inc.
- EUDAMED SRN
- US-MF-000003761
- Authorised Representative
- Directa AB SE-AR-000002492
Sources (10)
- EUDAMED ed0d2bf4-167b-458d-8955-573146bd84de 61 fields · synced Jul 28, 2026
- EUDAMED 6229f367-e83d-4f01-a639-ce0acc23d8b3 61 fields · synced May 17, 2026
- EUDAMED c9e78d22-11c3-44fc-b603-939ee0844a63 61 fields · synced May 18, 2026
- FDA UDI 4fea3ecd-bbd1-42c2-84cb-a1e083ea8b64 35 fields · synced May 29, 2026
- FDA UDI 4eb17da7-40f3-4790-81bd-f4fad03e424d 36 fields · synced May 29, 2026
- FDA UDI 7cd49db8-f892-45c8-a07b-b9ce0662ad01 35 fields · synced May 30, 2026
- FDA UDI 9b6df235-58b6-4001-9c2c-99441ed1117a 35 fields · synced May 30, 2026
- EUDAMED d19ce5f0-89be-4bc5-baa5-d2ee5d1793e6 61 fields · synced Jul 10, 2026
- EUDAMED 6627ea63-d7c4-4aa2-819c-d2eb6d14b558 61 fields · synced Jul 10, 2026
- EUDAMED 91d670d9-37ba-411b-83d8-7a1eda22d774 61 fields · synced Jul 11, 2026