Seal Block Pro (Not Finalized), Seal Block OTC (Not Finalized)
FDA 510(k) K123653 · Bisco, Inc.
510(k) numberK123653
Submission
- Device name
- Seal Block Pro (Not Finalized), Seal Block OTC (Not Finalized)
- Applicant
- Bisco, Inc.
Schaumburg, IL, US - Received
- November 27, 2012
- Decision date
- June 3, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K180344 | TheraCal DCEJK · Special | 04/05/2018SE |
| K171147 | REVEAL BulkEBF · Traditional | 08/04/2017SE |
| K162598 | HAPI SealEBC · Traditional | 05/23/2017SE |
| K163171 | CeraCleanPME · Traditional | 04/14/2017SE |
| K161051 | All-Bond Universal w/BAC (not finalized)KLE · Traditional | 09/09/2016SE |
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Questions and answers
When was Seal Block Pro (Not Finalized), Seal Block OTC (Not Finalized) cleared by the FDA?
Seal Block Pro (Not Finalized), Seal Block OTC (Not Finalized) (K123653) received a 510(k) decision of Substantially Equivalent on June 3, 2013, 188 days after the submission was received.
What is the product code of K123653?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.