Opal Seal
FDA 510(k) K090355 · Ultradent Products, Inc.
510(k) numberK090355
Submission
- Device name
- Opal Seal
- Applicant
- Ultradent Products, Inc.
South Jordan, UT, US - Received
- February 11, 2009
- Decision date
- April 29, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DYH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261129 | OrthoFitDYH · Traditional | Spident Co., Ltd. | 07/02/2026SE |
| K261840 | BracePaste Prime PlusDYH · Traditional | American Orthodontics | 06/03/2026SE |
| K250015 | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree AdhesiveDYH · Traditional | Ormco Corporation | 01/03/2025SE |
| K242537 | BracePaste Fluoride SealantDYH · Traditional | American Orthodontics Corp. | 08/27/2024SE |
| K234043 | 3M Transbond Orthodontic AdhesiveDYH · Traditional | 3M Unitek Orthodontic Products | 12/22/2023SE |
| K231817 | AlignerFlow LCDYH · Traditional | Voco GmbH | 12/01/2023SE |
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP…DYH · Traditional | Tp Orthodontics, Inc. | 10/14/2022SE |
| K210115 | FiteBac CC OrthoSealDYH · Traditional | Largent Health, LLC | 07/29/2021SE |
| K202276 | BracePaste Band and Build LCDYH · Traditional | American Orthodontics | 08/14/2020SE |
| K192682 | Orthocem, Ortho BiteDYH · Traditional | Dentscare Ltda | 08/14/2020SE |
More from Dentscare Ltda
| 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 Opal Seal cleared by the FDA?
Opal Seal (K090355) received a 510(k) decision of Substantially Equivalent on April 29, 2009, 77 days after the submission was received.
What is the product code of K090355?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.