Identity
- Trade Name
- SciPharm Band Secure Orthodontic Band Cement FDA UDI
- Generic Name
- Dentine adhesive FDA UDI
- Device Name
- Band Secure - Orthodontic Band Cement with Fluoride. FDA UDI
- Model / Reference
- SP 62-01 FDA UDI
- Description
- Band Secure - Orthodontic Band Cement with Fluoride. FDA UDI
Identifiers
- Catalog Number
- 62-01 FDA UDI
- Primary DI / UDI-DI
- D801SP62011 FDA UDI
- 510(k) Number
- K001446 FDA UDI
- FDA Product Code
- DYH FDA UDI
- GMDN Term
- Dentine adhesive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3750 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Category: Dentine adhesive
SciPharm Band Secure Orthodontic Band Cement by Scientific Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dentine adhesive.
- SEPTODONT HZ IMAGE MH COMP L/C SYR KIT — Septodont · Class II
- Peak Universal Bond — ULTRADENT PRODUCTS, INC. · Class II
- E-ON — BENCO DENTAL SUPPLY CO. · Class II
- PermaFlo DC — ULTRADENT PRODUCTS, INC. · Class II
- Xeno® IV One Component Light Cured Self-Etching Dental Adhesive — Dentsply International · Class II
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
- Prime&Bond® NT™ Nano-Technology Light Cured Dental Adhesive — Dentsply International · Class II
- Tokuyama Bond Force — TOKUYAMA DENTAL CORPORATION · Class II
Cleared under the same submission
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
- Scientific Pharmaceuticals, Inc.
Sources (1)
- FDA UDI f8a7aa28-ee76-4e44-bb16-a27813fbaf81 37 fields · synced Jun 8, 2026