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Ormco EtchFree Adhesive, Syringe Refill
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 740-0510
Identity
- Trade Name
- Ormco™ EtchFree Bonding FDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- Ormco EtchFree Adhesive, Syringe Refill EUDAMEDFDA UDI
- Model / Reference
- 740-0510 EUDAMEDFDA UDI
- Description
- ORMCO ETCHFREE ADHESIVE, SYRINGE REFILL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989088892 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889989-Pmr_EtchFree-6U EUDAMED
- Direct Marketing DI
- 00889989088892 EUDAMED
- FDA Product Code
- DYH FDA UDI
- EMDN Code
- Q01010104 DENTAL BONDING AGENTS EUDAMED
- GMDN Term
- Orthodontic bracket adhesive FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3750 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 4 Gram FDA UDI
Category: Dentine bonding agent/set
Ormco EtchFree Adhesive, Syringe Refill by Ormco Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Dentine bonding agent/set.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0889989-Pmr_EtchFree-6U | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ormco Corporation
- EUDAMED SRN
- US-MF-000038085
- Authorised Representative
- KERR ITALIA SRL IT-AR-000007600
Sources (2)
- EUDAMED 259bb841-2594-45f4-a217-d2a5e41165f0 61 fields · synced Jul 11, 2026
- FDA UDI 517e7703-b4cb-40cd-a80d-e70e08e93c2c 36 fields · synced May 30, 2026