Identity
- Trade Name
- Bite-Bumper™ FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Bite-Bumper™ - Palatal bite raiser for raising a deep overbite in Class II treatment FDA UDI
- Model / Reference
- 705-000-00 FDA UDI
- Description
- Bite-Bumper™ - Palatal bite raiser for raising a deep overbite in Class II treatment FDA UDI
Identifiers
- Primary DI / UDI-DI
- J011705000000 FDA UDI
- FDA Product Code
- DYW FDA UDI
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Bite-Bumper™ by Dentaurum — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Dentaurum
Sources (1)
- FDA UDI eb9c72af-807d-4b30-bce7-d78e5dfccb15 36 fields · synced May 31, 2026