Identity
- Trade Name
- Self Etching primer FDA UDI
- Generic Name
- Dental etching solution FDA UDI
- Device Name
- The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation of an enamel surface of a tooth prior to bonding with a light cure orthodontic adhesive.S.E.P College Kit – 1x S.E.P. Refill Cartridge -Ref# SEPR Light Impervious Mixing Well – Ref# SEPW 50 x Microbrushes -Ref# MB S.E.P Dispenser -Ref# SEPD FDA UDI
- Model / Reference
- SEPC FDA UDI
- Description
- The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation of an enamel surface of a tooth prior to bonding with a light cure orthodontic adhesive.S.E.P College Kit – 1x S.E.P. Refill Cartridge -Ref# SEPR Light Impervious Mixing Well – Ref# SEPW 50 x Microbrushes -Ref# MB S.E.P Dispenser -Ref# SEPD FDA UDI
Identifiers
- Catalog Number
- SEPC FDA UDI
- Primary DI / UDI-DI
- D798SEPC0 FDA UDI
- 510(k) Number
- K071688 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dental etching solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 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
Self Etching primer 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 7a8ff8d1-6a24-4f8b-8502-9287a3ae33a8 38 fields · synced May 30, 2026