Orthodontic Bracket Adhesive
FDA 510(k) K771076 · Lee Pharmaceuticals
510(k) numberK771076
Submission
- Device name
- Orthodontic Bracket Adhesive
- Applicant
- Lee Pharmaceuticals
Mchenry, IL, US - Received
- June 15, 1977
- Decision date
- June 24, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 510(k) | Device | Decision |
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| K924378 | Restobond 4KLE · Traditional | 03/31/1993SE |
| K912256 | Precise(R) Beta Quartz Glass-Ceramic InsertKLE · Traditional | 07/24/1991SE |
| K900809 | Lee-Fischer Ceramic Reinforced Plastic BracketsDYW · Traditional | 06/28/1990SE |
| K894315 | Restobond 3/DENTIN-ENAMEL Bonding AgentKLE · Traditional | 10/31/1989SE |
| K881903 | Prosthodent VLEBF · Traditional | 07/01/1988SE |
| K873123 | Lee Composite Inlay SystemEBF · Traditional | 01/20/1988SE |
| K863157 | Restodent PosteriorEBF · Traditional | 09/25/1986SE |
| K854882 | Protec/Visible Light-Cured Sealant/Dental RestoratEBC · Traditional | 01/30/1986SE |
| K844134 | Cleanse N Bond IIDYH · Traditional | 01/04/1985SE |
| K844133 | Cleanse N Bond IDYH · Traditional | 01/04/1985SE |
Questions and answers
When was Orthodontic Bracket Adhesive cleared by the FDA?
Orthodontic Bracket Adhesive (K771076) received a 510(k) decision of Substantially Equivalent on June 24, 1977, 9 days after the submission was received.
What is the product code of K771076?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.