Magic-Touch
FDA 510(k) K810210 · Sci-Pharm, Inc.
510(k) numberK810210
Submission
- Device name
- Magic-Touch
- Applicant
- Sci-Pharm, Inc.
Mchenry, IL, US - Received
- January 26, 1981
- Decision date
- February 10, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K261129 | OrthoFitDYH · Traditional | Spident Co., Ltd. | 07/02/2026SE |
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| 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 |
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More from Dentscare Ltda
| 510(k) | Device | Decision |
|---|---|---|
| K823935 | Micro Join, Crown & Bridge AdhesiveEMA · Traditional | 02/07/1983SE |
| K820092 | Secure-On-TouchDYH · Traditional | 02/24/1982SE |
| K813091 | Fissure Sealer & Bonding AgentEBC · Traditional | 11/24/1981SE |
| K813090 | Composite Dental Restorative MaterialEBF · Traditional | 11/24/1981SE |
| K812550 | BeaucavLBH · Traditional | 09/25/1981SE |
| K812549 | BeausealEBC · Traditional | 09/25/1981SE |
| K812548 | CobeauLBH · Traditional | 09/25/1981SE |
| K812546 | BeaudentEBF · Traditional | 09/25/1981SE |
| K812545 | BeaufillEBF · Traditional | 09/25/1981SE |
| K812551 | BeaucorEBF · Traditional | 09/23/1981SE |
Questions and answers
When was Magic-Touch cleared by the FDA?
Magic-Touch (K810210) received a 510(k) decision of Substantially Equivalent on February 10, 1981, 15 days after the submission was received.
What is the product code of K810210?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.