Identity
- Trade Name
- Eagle Spectrum FDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- EAGLE SPECTRUM LIGHT CURE SEALANT 6 GMS FDA UDI
- Model / Reference
- 001-942 FDA UDI
- Description
- EAGLE SPECTRUM LIGHT CURE SEALANT 6 GMS FDA UDI
Identifiers
- Catalog Number
- 001-942 FDA UDI
- Primary DI / UDI-DI
- 00190746007729 FDA UDI
- 510(k) Number
- K831495 FDA UDI
- FDA Product Code
- DYH FDA UDI
- GMDN Term
- Orthodontic bracket 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
No
FDA UDI
Category: Orthodontic bracket adhesive
Eagle Spectrum by American Orthodontics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthodontic bracket adhesive.
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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
- 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.
- SciPharm CuRay 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
- American Orthodontics
Sources (1)
- FDA UDI 3261c08b-12a6-4c8c-b484-398c24533821 37 fields · synced Jun 9, 2026