Dentaurum Mix Two-Paste Bracket Adhesive
FDA 510(k)Class II (US FDA 510(k))
by Dentaurum
Identifiers
- 510(k) Number
- K030977 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 Dentaurum Mix Two-Paste Bracket Adhesive is a self-cure resin system designed for orthodontic applications. It consists of two pastes that are mixed by a clinician to initiate polymerization, facilitating the bonding of orthodontic brackets to tooth enamel.
This device is used in conjunction with a liquid primer and phosphoric acid etching gel by dental professionals in a clinical setting. It is authorized via FDA 510(k) clearance under regulation number 872.3750.
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: DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE (K030977) — FDA 510 (k ..., Dentaurum Mix Two-paste Bracket Adhesive - Beudamed, PDF p*L. 4 DEPARTMENTOFHEALI'H8rHUMANSERVICES Public Health Service
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030977 | Class II | Active |
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Manufacturer
- Manufacturer
- Dentaurum
Sources (1)
- FDA 510(k) K030977 24 fields · synced Sep 24, 2026