J & J Light Curing Dentin/Enamel Bonding Agent
FDA 510(k) K850073 · Johnson & Johnson Professionals, Inc.
510(k) numberK850073
Submission
- Device name
- J & J Light Curing Dentin/Enamel Bonding Agent
- Applicant
- Johnson & Johnson Professionals, Inc.
East Windsor, NJ, US - Received
- January 9, 1985
- Decision date
- February 8, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was J & J Light Curing Dentin/Enamel Bonding Agent cleared by the FDA?
J & J Light Curing Dentin/Enamel Bonding Agent (K850073) received a 510(k) decision of Substantially Equivalent on February 8, 1985, 30 days after the submission was received.
What is the product code of K850073?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.