Identity
- Trade Name
- Illuminate FDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- ILLUMINATE LIGHT-CURE ADHESIVE KIT FDA UDI
- Model / Reference
- 471-050 FDA UDI
- Description
- ILLUMINATE LIGHT-CURE ADHESIVE KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190707041229 FDA UDI
- 510(k) Number
- K935625 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
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
Category: Orthodontic bracket adhesive
Illuminate by Ortho Organizers, Inc. — 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
- 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
- ORTHOSOURCE — Ortho Source · Class II
Cleared under the same submission
K935625 also covers:
- ALPHA-DENT® Light Cure Bracket Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Bracket Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Bracket Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Bracket Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Bracket Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Bracket Bonding Resin — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Bracket Bonding Resin — Dental Technologies, Inc.
- ORAPRO — ORTHOQUEST, INC.
- ORAPRO — ORTHOQUEST, INC.
- ORAPRO — ORTHOQUEST, INC.
- ORAPRO — ORTHOQUEST, INC.
- ORAPRO — ORTHOQUEST, 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
- Ortho Organizers, Inc.
Sources (1)
- FDA UDI b3e3c502-a713-4a27-a044-fd801dc5c959 35 fields · synced Jun 9, 2026