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Pitts21® PRO
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 956.2032Model P21 PRO 5X5 U/L HKS 345
Identity
- Trade Name
- Pitts21® PRO EUDAMEDPitts21 PRO FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Pitts21 PRO Passive Self-Ligating Bracket System EUDAMEDP21 PRO 5X5 U/L HKS 345 FDA UDI
- Model / Reference
- P21 PRO 5X5 U/L HKS 345 EUDAMED956.2032 EUDAMEDFDA UDI
- Description
- P21 PRO 5X5 U/L HKS 345 FDA UDI
Identifiers
- Catalog Number
- 956.2032 FDA UDI
- Primary DI / UDI-DI
- 00840273900238 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840273900238 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
- Poland 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® PRO 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-00840273900238 | 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 ada165d0-9aaf-4269-a810-f15ebcb352b1 61 fields · synced Jul 8, 2026
- FDA UDI 8ad0d94a-96eb-43fc-a986-8e9ee49d9cc6 35 fields · synced May 26, 2026