No-Mix 30 Orthodontic Bonding System
FDA 510(k) K832112 · Scientific Pharmaceuticals, Inc.
510(k) numberK832112
Submission
- Device name
- No-Mix 30 Orthodontic Bonding System
- Applicant
- Scientific Pharmaceuticals, Inc.
Mchenry, IL, US - Received
- June 30, 1983
- Decision date
- August 31, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K982915 | Sci-Pharm DFV VarnishLBH · Traditional | 02/12/1999SE |
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Questions and answers
When was No-Mix 30 Orthodontic Bonding System cleared by the FDA?
No-Mix 30 Orthodontic Bonding System (K832112) received a 510(k) decision of Substantially Equivalent on August 31, 1983, 62 days after the submission was received.
What is the product code of K832112?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.