Identity
- Trade Name
- Phase II FDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances. The highly-filled paste provides a strong mechanical bond with metal and ceramic bracket bases. Kit contains: 18g Catalyst Paste A with fluoride, 18g Base Paste B, 7g Bonding Resin A with fluoride &B, 9g Liquid Etchant, mixing pad, spatulas, disposable brushes. This kit with 3 X 6g Screw Syringes paste A & B, 20g Sealant Resin A & B, 23g Etchant. Contains Fluoride.. FDA UDI
- Model / Reference
- PESF FDA UDI
- Description
- Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances. The highly-filled paste provides a strong mechanical bond with metal and ceramic bracket bases. Kit contains: 18g Catalyst Paste A with fluoride, 18g Base Paste B, 7g Bonding Resin A with fluoride &B, 9g Liquid Etchant, mixing pad, spatulas, disposable brushes. This kit with 3 X 6g Screw Syringes paste A & B, 20g Sealant Resin A & B, 23g Etchant. Contains Fluoride.. FDA UDI
Identifiers
- Catalog Number
- PESF FDA UDI
- Primary DI / UDI-DI
- D798PESF0 FDA UDI
- 510(k) Number
- K895523 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
- Not 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
Phase II by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 ba51d7bf-234b-485e-a7c1-7c677b985a15 38 fields · synced May 30, 2026