Adhesive, Bracket and Tooth Conditioner Resin
FDA 510(k) K921283 · Jeneric/Pentron, Inc.
510(k) numberK921283
Submission
- Device name
- Adhesive, Bracket and Tooth Conditioner Resin
- Applicant
- Jeneric/Pentron, Inc.
Wallingford, CT, US - Received
- March 17, 1992
- Decision date
- December 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K020499 | BOND-3 AdhesiveKLE · Traditional | 04/22/2002SE |
| K013543 | BOND-1 C & BKLE · Traditional | 02/22/2002SE |
| K013542 | Dentin Conditioning and Adhesive System (BOND-1)KLE · Traditional | 02/14/2002SE |
| K012231 | Avante Micro Crystal SystemEIH · Traditional | 08/23/2001SE |
| K011748 | First Fill R.C.S.KIF · Traditional | 08/03/2001SE |
| K010957 | Quell DesensitizerLBH · Traditional | 06/25/2001SE |
| K011331 | JP Cast 40EJT · Traditional | 06/22/2001SE |
| K011330 | JP Cast 50EJT · Traditional | 06/22/2001SE |
| K011362 | Gold Core 73 LSEJT · Traditional | 05/29/2001SE |
| K010044 | CosmicEJT · Traditional | 02/09/2001SE |
Questions and answers
When was Adhesive, Bracket and Tooth Conditioner Resin cleared by the FDA?
Adhesive, Bracket and Tooth Conditioner Resin (K921283) received a 510(k) decision of Substantially Equivalent on December 23, 1992, 281 days after the submission was received.
What is the product code of K921283?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.