American Dental Products Two Paste Adhesive Orthodontic Bonding System W/Fluoride
FDA 510(k) K954372 · American Dental Products, Inc.
510(k) numberK954372
Submission
- Device name
- American Dental Products Two Paste Adhesive Orthodontic Bonding System W/Fluoride
- Applicant
- American Dental Products, Inc.
Medinah, IL, US - Received
- September 19, 1995
- Decision date
- October 17, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K954876 | American Dental Products Root Canal Sealer, Wach's FormulaEMA · Traditional | 11/15/1995SE |
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| K954408 | American Dental Products Light Activated Composite Resin Core Buildup Blue PasteeEBF · Traditional | 10/30/1995SE |
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Questions and answers
When was American Dental Products Two Paste Adhesive Orthodontic Bonding System W/Fluoride cleared by the FDA?
American Dental Products Two Paste Adhesive Orthodontic Bonding System W/Fluoride (K954372) received a 510(k) decision of Substantially Equivalent on October 17, 1995, 28 days after the submission was received.
What is the product code of K954372?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.