Sci-Pharm Orthodontic Adhesive
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K791132 FDA 510(k)
- FDA Product Code
- DYH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3750 FDA 510(k)
- Regulation Number
- 872.3750 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sci-Pharm Orthodontic Adhesive is a resin-based adhesive, bracket, and tooth conditioner. It is designed for use in orthodontic procedures to facilitate the bonding of brackets to teeth.
This device is regulated as a Class 2 medical device under FDA 510(k) authorization K791132. It is intended for professional dental use as specified in the premarket notification.
Frequently asked questions
What is the primary use of the Sci-Pharm Orthodontic Adhesive?
This device is a resin-based adhesive, bracket, and tooth conditioner intended for professional dental use. It is specifically designed to facilitate the bonding of orthodontic brackets to teeth during orthodontic procedures.
How is this device regulated?
The Sci-Pharm Orthodontic Adhesive is regulated as a Class 2 medical device. It received FDA 510(k) authorization under the number K791132, which indicates it was found to be substantially equivalent to other legally marketed devices.
Who is the intended user for this product?
This adhesive system is intended for professional dental use only. It is designed to be utilized by trained dental practitioners within the scope of orthodontic procedures as specified in the premarket notification.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Welcome to Sci-Pharm, Welcome to Sci-Pharm, SCI-PHARM ORTHODONTIC ADHESIVE (K791132) — FDA 510 (k) | Innolitics, Sci-pharm Orthodontic Adhesive 510 (k) FDA Premarket Notification ..., Sci-pharm Orthodontic Adhesive - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K791132 | Class II | Active |
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Manufacturer
- Manufacturer
- Scientific Pharmaceuticals, Inc.
Sources (1)
- FDA 510(k) K791132 24 fields · synced Sep 26, 2026