Identity
- Trade Name
- Fascination® FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- Fascination® 2 Bracket, - 22° Torque, 0° Angulation for tooth 45 FDA UDI
- Model / Reference
- 700-030-11 FDA UDI
- Description
- Fascination® 2 Bracket, - 22° Torque, 0° Angulation for tooth 45 FDA UDI
Identifiers
- Primary DI / UDI-DI
- J011700030110 FDA UDI
- 510(k) Number
- K935139 FDA UDI
- FDA Product Code
- EJF FDA UDI
- GMDN Term
- Orthodontic bracket, ceramic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Discover the Fascination device, a cutting-edge ceramic orthodontic bracket designed for single-patient use. This versatile system allows dentists to apply pressure to teeth using an archwire/bracket fixation ring, creating a stable and lasting solution for tooth movement. With its compact design and secure attachment mechanism, the Fascination ensures optimal results while minimizing storage requirements.
Cleared under the same submission
K935139 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dentaurum
Sources (1)
- FDA UDI 4a137b12-6acc-48b8-a259-1f37e882305a 37 fields · synced Aug 3, 2026