Identity
- Trade Name
- Ultra Band Lok FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Ultra Band-Lok is intended for use as an orthodontic band cement and for occlusal buildups. Ultra Band-Lok can also be used to bond brackets, lingual retainers and large acrylic appliances. This product is in Blue Shade which will contrast the enamel and facilitate removal of material before and after treatment. Luer Lok Ultra Band Lok kit contains: 6 5g Luer Lok Blue Adhesive Syringes with 60 tips. FDA UDI
- Model / Reference
- LLUBLB FDA UDI
- Description
- Ultra Band-Lok is intended for use as an orthodontic band cement and for occlusal buildups. Ultra Band-Lok can also be used to bond brackets, lingual retainers and large acrylic appliances. This product is in Blue Shade which will contrast the enamel and facilitate removal of material before and after treatment. Luer Lok Ultra Band Lok kit contains: 6 5g Luer Lok Blue Adhesive Syringes with 60 tips. FDA UDI
Identifiers
- Catalog Number
- LLUBLB FDA UDI
- Primary DI / UDI-DI
- D798LLUBLB0 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Ultra Band Lok by Reliance Orthodontic Products, Inc. — 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
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI 29e9d78c-c556-4d88-857b-993796f5e656 37 fields · synced Jun 8, 2026