Command Bonding Resin/Glaze/Opaquer
FDA 510(k) K822869 · Sybron Corp.
510(k) numberK822869
Submission
- Device name
- Command Bonding Resin/Glaze/Opaquer
- Applicant
- Sybron Corp.
Mchenry, IL, US - Received
- September 27, 1982
- Decision date
- October 13, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Command Bonding Resin/Glaze/Opaquer cleared by the FDA?
Command Bonding Resin/Glaze/Opaquer (K822869) received a 510(k) decision of Substantially Equivalent on October 13, 1982, 16 days after the submission was received.
What is the product code of K822869?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.