Secure-On-Touch
FDA 510(k) K820092 · Sci-Pharm, Inc.
510(k) numberK820092
Submission
- Device name
- Secure-On-Touch
- Applicant
- Sci-Pharm, Inc.
Mchenry, IL, US - Received
- January 13, 1982
- Decision date
- February 24, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Dentscare Ltda
| 510(k) | Device | Decision |
|---|---|---|
| K823935 | Micro Join, Crown & Bridge AdhesiveEMA · Traditional | 02/07/1983SE |
| 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 |
| K812547 | BeaubonDYH · Traditional | 09/23/1981SE |
Questions and answers
When was Secure-On-Touch cleared by the FDA?
Secure-On-Touch (K820092) received a 510(k) decision of Substantially Equivalent on February 24, 1982, 42 days after the submission was received.
What is the product code of K820092?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.