Identity
- Trade Name
- OrthoEasy® FDA UDI
- Generic Name
- Orthodontic appliance system, bonded FDA UDI
- Device Name
- Accessories for OrthoEasy EUDAMEDPalatal abutment FDA UDI
- Model / Reference
- 1299-1004 EUDAMEDFDA UDI
- Description
- Palatal abutment FDA UDI
Identifiers
- Primary DI / UDI-DI
- EFOR129910041 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EFOR100102D3 EUDAMED
- Unit of Use DI
- EFOR12991004001 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic appliance system, bonded FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthodontic appliance system, bonded
OrthoEasy® by Forestadent Bernhard Förster GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Forestadent Bernhard Förster GmbH
Sources (2)
- FDA UDI 27d892d3-deba-45d0-99e6-6de16537df2b 34 fields · synced Jun 18, 2026
- EUDAMED 7494cddc-7648-4e8b-abed-0fad0f5201b6 61 fields · synced Jun 18, 2026