Seal & Bond Direct Bonding Orthodontic
FDA 510(k) K790962 · Scientific Pharmaceuticals, Inc.
510(k) numberK790962
Submission
- Device name
- Seal & Bond Direct Bonding Orthodontic
- Applicant
- Scientific Pharmaceuticals, Inc.
Mchenry, IL, US - Received
- May 22, 1979
- Decision date
- July 6, 1979
- 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 Seal & Bond Direct Bonding Orthodontic cleared by the FDA?
Seal & Bond Direct Bonding Orthodontic (K790962) received a 510(k) decision of Substantially Equivalent on July 6, 1979, 45 days after the submission was received.
What is the product code of K790962?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.