Ultraez Desensitizing Gel
FDA 510(k) K061438 · Ultradent Products, Inc.
510(k) numberK061438
Submission
- Device name
- Ultraez Desensitizing Gel
- Applicant
- Ultradent Products, Inc.
South Jordan, UT, US - Received
- May 24, 2006
- Decision date
- June 12, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262243 | Profisil FreeLBH · Traditional | Kettenbach GmbH & Co. KG | 09/03/2026SE |
| K253052 | Fluoride Varnish (Type A,Type C)LBH · Traditional | Nagy Oral Technology Qinhuangdao Co., Ltd. | 06/11/2026SE |
| K252073 | VOCO Profluorid Varnish + BioMinLBH · Traditional | Voco GmbH | 05/01/2026SE |
| K261404 | UltraEZLBH · Special | Ultradent Products, Inc. | 04/30/2026SE |
| K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)LBH · Traditional | Sangi Co., Ltd. | 03/18/2026SE |
| K250714 | FluoroDose VarnishLBH · Traditional | Centrix, Inc. | 11/21/2025SE |
| K243777 | Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3%…LBH · Traditional | Theodent, LLC | 05/27/2025SE |
| K241489 | ReminGelLBH · Traditional | Inter-Med, Inc. | 01/08/2025SE |
| K241568 | CrystLCare PRO Biorestorative, Fluoride-PlusLBH · Traditional | GreenMark Biomedical, Inc. | 01/02/2025SE |
| K242913 | Jasmate® ToothpasteLBH · Traditional | Jasberry Healthcare Private Limited | 11/22/2024SE |
More from Jasberry Healthcare Private Limited
| 510(k) | Device | Decision |
|---|---|---|
| K262228 | Transcend Bulk Fill Flowable CompositeEBF · Traditional | 07/01/2026SE |
| K261404 | UltraEZLBH · Special | 04/30/2026SE |
| K240743 | Peak Universal BondKLE · Special | 03/20/2024SE |
| K240694 | FORMA Composite (Shade A3D)EBF · Traditional | 03/15/2024SE |
| K221909 | J-TempEBF · Traditional | 07/01/2022SE |
| K220471 | VALO X, VALO X Accessory LensesEBZ · Traditional | 02/22/2022SE |
| K211905 | UltraCal XSKIF · Traditional | 10/13/2021SE |
| K211237 | UltraTemp Rez IIEMA · Traditional | 07/13/2021SE |
| K210550 | VALO Grand Corded and Accessory LensesEBZ · Traditional | 03/01/2021SE |
| K190627 | VALO Grand CordedEBZ · Special | 04/29/2019SE |
Questions and answers
When was Ultraez Desensitizing Gel cleared by the FDA?
Ultraez Desensitizing Gel (K061438) received a 510(k) decision of Substantially Equivalent on June 12, 2007, 384 days after the submission was received.
What is the product code of K061438?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.