Class II — Ultradent Products, Inc.
| Recalling firm | ULTRADENT PRODUCTS, INC. |
|---|---|
| Registered facility | Ultradent Products Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that connects to the syringe. |
| Product | NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from 304 SS, and is 30-gauge in diameter and 0.488 in length. The cannula is secured in the base with an epoxy adhesive. Indications: Tips, when used in conjunction with the range of available syringes and products, provide a technique that is designed to provide a faster, easier, and more precise delivery. They are design… |
| Quantity | 143 packs of 100 tips; 104 packs of 20 tips |
| Distribution | Worldwide Distribution - US (Nationwide) - Internationally to Belgium, Switzerland, Germany, Italy, South Korea, Netherlands, and Japan. |
| Initiated | 2016-12-14 |
| Classified | 2017-01-17 |
| Terminated | 2017-06-05 |
| Recall number | Z-1034-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ultradent Products, Inc. (Z-1034-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76039/
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