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Pitts21™
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 946.2004-10Model P21 UL2 21/6/9/0 10PK
Identity
- Trade Name
- Pitts21™ EUDAMEDPitts21 FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Pitts21™ Self-Ligating Bracket System EUDAMEDP21 UL2 21/6/9/0 10PK FDA UDI
- Model / Reference
- P21 UL2 21/6/9/0 10PK EUDAMED946.2004-10 EUDAMEDFDA UDI
- Description
- P21 UL2 21/6/9/0 10PK FDA UDI
Identifiers
- Catalog Number
- 946.2004-10 FDA UDI
- Primary DI / UDI-DI
- 00840273900627 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840273900627 EUDAMED
- FDA Product Code
- EJF FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Hungary EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pitts21™ by World Class Technology Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840273900627 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- World Class Technology Corporation
- EUDAMED SRN
- US-MF-000014389
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 8a8613d8-c1f4-4aac-b336-3419ef6c921c 61 fields · synced Jun 9, 2026
- FDA UDI 3fc9806a-fbbc-4e25-9da3-0af5504256bc 35 fields · synced May 30, 2026