Identity
- Trade Name
- Plastic Conditioner FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- The Reliance Plastic Appliance Conditioner is intended for use as a conditioner of plastic brackets or acrylic appliances in preparation for bonding with any adhesive, sealant or cement. It can also be used to condition a composite restoration or acrylic jacket prior to bonding and to rebond a bracket impregnated with adhesive. 10 cc bottle FDA UDI
- Model / Reference
- PL FDA UDI
- Description
- The Reliance Plastic Appliance Conditioner is intended for use as a conditioner of plastic brackets or acrylic appliances in preparation for bonding with any adhesive, sealant or cement. It can also be used to condition a composite restoration or acrylic jacket prior to bonding and to rebond a bracket impregnated with adhesive. 10 cc bottle FDA UDI
Identifiers
- Catalog Number
- PL FDA UDI
- Primary DI / UDI-DI
- D798PL0 FDA UDI
- 510(k) Number
- K880792 FDA UDI
- FDA Product Code
- DYH FDA UDI
- GMDN Term
- Dentine bonding agent/set 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
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: Dentine bonding agent/set
Plastic Conditioner by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K880792 also covers:
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
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI 406322f6-2dac-468b-9412-e796e7e8f313 37 fields · synced Jun 6, 2026