Identity
- Trade Name
- Ortho Bite FDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- Ortho Bite is a light-curing self-adhesive composite with self-levelling characteristics and surface hardness. The product is indicated for cementing orthodontic bands and is also suitable for temporary dental disocclusion during orthodontic treatment. The product is colored in order to facilitate its identification during application and removal. FDA UDI
- Model / Reference
- 4g FDA UDI
- Description
- Ortho Bite is a light-curing self-adhesive composite with self-levelling characteristics and surface hardness. The product is indicated for cementing orthodontic bands and is also suitable for temporary dental disocclusion during orthodontic treatment. The product is colored in order to facilitate its identification during application and removal. FDA UDI
Identifiers
- Catalog Number
- 4000019365 FDA UDI
- Primary DI / UDI-DI
- 07899633815982 FDA UDI
- FDA Product Code
- EBF FDA UDIDYH FDA UDI
- GMDN Term
- Orthodontic bracket adhesive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI872.3750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Category: Orthodontic bracket adhesive
Ortho Bite by Dentscare Ltda — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Dentscare Ltda
Sources (1)
- FDA UDI 2db04e89-5d71-44ad-9ac2-15577334f34a 34 fields · synced May 30, 2026