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Ceramaflex Bracket System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K950992

by Tp Orthodontics, Inc.

Identifiers

510(k) Number
K950992 FDA 510(k)
FDA Product Code
NJM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.5470 FDA 510(k)
Regulation Number
872.5470 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Ceramaflex Bracket System is a ceramic orthodontic bracket device. It is classified as a Class II medical device under FDA regulation number 872.5470 and product code NJM.

The device received FDA 510(k) clearance (K950992) on May 3, 1995, and is substantially equivalent to a legally marketed predicate device. It is manufactured by TP Orthodontics, Inc. and is intended for use in dental orthodontic applications.

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: Home - TP Orthodontics, CERAMAFLEX BRACKET SYSTEM (K950992) — FDA 510(k) | Innolitics, Ceramaflex Bracket System 510 (k) FDA Premarket Notification K950992 TP ..., Products - TP Orthodontics, TP ORTHODONTICS, INC. FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tp Orthodontics, Inc.

Sources (1)

  • FDA 510(k) K950992 24 fields · synced Sep 22, 2026