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SciPharm CuRay Eclipse Visible Light-Cured Orthodontic Adhesive
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- SciPharm CuRay Eclipse Visible Light-Cured Orthodontic Adhesive FDA UDI
- Generic Name
- Dentine adhesive FDA UDI
- Device Name
- CuRay Eclipse Visible Light-Cured Orthodontic Adhesive. Carpule. Boxed. FDA UDI
- Model / Reference
- SP 60-053 CB FDA UDI
- Description
- CuRay Eclipse Visible Light-Cured Orthodontic Adhesive. Carpule. Boxed. FDA UDI
Identifiers
- Catalog Number
- 60-053 FDA UDI
- Primary DI / UDI-DI
- D801SP60053CB1 FDA UDI
- 510(k) Number
- K831495 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 CuRay Eclipse Visible Light-Cured Orthodontic Adhesive by Scientific Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID
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
K831495 also covers:
- Eagle No Drift — American Orthodontics
- Eagle No Drift — American Orthodontics
- Eagle Spectrum — American Orthodontics
- Eagle Spectrum — American Orthodontics
- Eagle Spectrum — American Orthodontics
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- International Dental Supply Eclipse Visible Light-Cured Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, INC.
- International Dental Supply Eclipse Visible Light-Cured Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, INC.
- International Dental Supply Eclipse Visible Light-Cured Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, INC.
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
- Scientific Pharmaceuticals, Inc.
Sources (1)
- FDA UDI 25d7a28d-d30c-412d-b756-c001b8873be3 37 fields · synced May 30, 2026