Identity
- Trade Name
- Orthocem FDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- Orthocem is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the enamel surface. It has a fluorescent substance that allows tracing the product when applying ultraviolet light, facilitating product removal from teeth, after removing brackets. FDA UDI
- Model / Reference
- 4g FDA UDI
- Description
- Orthocem is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the enamel surface. It has a fluorescent substance that allows tracing the product when applying ultraviolet light, facilitating product removal from teeth, after removing brackets. FDA UDI
Identifiers
- Catalog Number
- 4000055255 FDA UDI
- Primary DI / UDI-DI
- 07899633826582 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
Orthocem by Dentscare Ltda — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic bracket adhesive.
- Opal Bond — ULTRADENT PRODUCTS, INC. · Class I
- ORTHOSOURCE — Ortho Source
- Resilience — ORTHO TECHNOLOGY, INC. · Class II
- Illuminate — Ortho Organizers, Inc. · Class II
- Novocol GRANITEC PRIMER 9ML — Septodont · Class II
- Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
- Light Cure Retainer — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
- Rely a Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentscare Ltda
Sources (1)
- FDA UDI 133cb542-4ae5-4c09-8701-11cecfee2843 34 fields · synced Jun 1, 2026