Identity
- Trade Name
- Spirit FDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- NO-MIX PRIMER - KIT FDA UDI
- Model / Reference
- 740-0077 FDA UDI
- Description
- NO-MIX PRIMER - KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989061512 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
Dimensions & Sizes
- Size
- Total Volume — 1.9 Milliliter FDA UDI
Category: Orthodontic bracket adhesive
Spirit by Ormco Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Rely a Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
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
- Ormco Corporation
Sources (1)
- FDA UDI b7d48e5f-c8be-4c5c-a81a-58cb1eae09fa 36 fields · synced Jun 9, 2026